A randomised controlled trial of lay health workers as direct observers for treatment of tuberculosis. Implementing community-based perinatal care: results from a pilot study in rural Pakistan. Global report on preterm birth and stillbirth (3 of 7): evidence for effectiveness of interventions. A randomized, controlled trial of nurse home visiting to vulnerable families with newborns. Lay health worker intervention with choice of DOT superior to standard TB care for farm dwellers in South Africa: a cluster randomised control trial. A trial of intermittent preventive treatment and home-based management of malaria in a rural area of The Gambia. The effect of a respiratory home nurse intervention in patients with chronic obstructive pulmonary disease (COPD). Home versus hospital breastfeeding support for newborns: a randomized controlled trial. L-thyroxine treatment of preterm newborns: clinical and endocrine effects. Trends in use of referral hospital services for care of sick newborns in a community-based intervention in Tangail District, Bangladesh. The effects of iron supplementation during pregnancy, given by traditional birth attendants, on the prevalence of anaemia and malaria. Paraprofessional women as health care facilitators in mother and child health. Promotion of Breastfeeding Intervention Trial (PROBIT): a randomized trial in the Republic of Belarus. Routinely available cotrimoxazole prophylaxis and occurrence of respiratory and diarrhoeal morbidity in infants born to HIV-infected mothers in South Africa. Community case management of fever due to malaria and pneumonia in children under five in Zambia: a cluster randomized controlled trial. Does supplementary prenatal nursing and home visitation support improve resource use in a universal health care system? A randomized controlled trial in Canada. A pilot randomized controlled trial of a breastfeeding self-efficacy intervention with primiparous mothers. Training in complementary feeding counselling of healthcare workers and its influence on maternal behaviours and child growth: a cluster-randomized controlled trial in Lahore, Pakistan. Staff training and ambulatory tuberculosis treatment outcomes: a cluster randomized controlled trial in South Africa. Effect of early postnatal breastfeeding support: a cluster-randomized community based trial. Reducing stillbirths: prevention and management of medical disorders and infections during pregnancy. Breastfeeding duration, costs, and benefits of a support program for low-income breastfeeding women. Topical application of chlorhexidine to neonatal umbilical cords for prevention of omphalitis and neonatal mortality in a rural district of Pakistan: a community-based, cluster-randomised trial. Kangaroo mother method: randomised controlled trial of an alternative method of care for stabilised low-birthweight infants. Maternidad Isidro Ayora Study Team. A trial of the effect of micronutrient supplementation on treatment outcome, T cell counts, morbidity, and mortality in adults with pulmonary tuberculosis. Adjunctive micronutrient supplementation for pulmonary tuberculosis. The effect of micronutrient supplementation on treatment outcome in patients with pulmonary tuberculosis: a randomized controlled trial in Mwanza, Tanzania. Feasibility of kangaroo mother care in Mumbai. Results of controlled double-blind study of thyroid replacement in very low-birth-weight premature infants with hypothyroxinemia. Effect of prenatal and infancy home visitation by nurses on pregnancy outcomes, childhood injuries, and repeated childbearing. A randomized controlled trial. Special features of health services and register based trials - experiences from a randomized trial of childbirth classes. Reducing stillbirths: behavioural and nutritional interventions before and during pregnancy. School health nurse interventions to increase immunisation uptake in school entrants. Effect of community-based newborn-care intervention package implemented through two service-delivery strategies in Sylhet district, Bangladesh: a cluster-randomised controlled trial. Pilot randomized trial of nutritional supplementation in patients with tuberculosis and HIV-tuberculosis coinfection receiving directly observed short-course chemotherapy for tuberculosis. Randomised controlled double blind study of role of recombinant erythropoietin in the prevention of chronic lung disease. A randomized trial of nurse-midwifery prenatal care to reduce low birth weight. Effect of training for care providers on practice of essential newborn care in hospitals in Sri Lanka. Impact of a statewide home visiting program on parenting and on child health and development. Postnatal thyroxine supplementation in infants less than 32 weeks' gestation: effects on pulmonary morbidity. Expanding developmental and behavioral services for newborns in primary care; Effects on parental well-being, practice, and satisfaction. Maternal outcomes of a randomized controlled trial of a community-based support program for families of children with chronic illnesses. Benefits of immunotherapy with a standardized Dermatophagoides pteronyssinus extract in asthmatic children: a three-year prospective study. Promoting secure attachment, maternal mood and child health in a vulnerable population: a randomized controlled trial. Effects of psychosocial support during labour and childbirth on breastfeeding, medical interventions, and mothers' wellbeing in a Mexican public hospital: a randomised clinical trial. A RCT of peer-mentoring for first-time mothers in socially disadvantaged areas (the MOMENTS Study). Influenza vaccination of health care workers in long-term-care hospitals reduces the mortality of elderly patients. [The nutritional status change the effectiveness of a dietary supplement of lactic bacteria on the emerging of respiratory tract diseases in children]. Child and family outcomes of a long-term nurse home visitation programme: a randomised controlled trial. Efficacy of breastfeeding support provided by trained clinicians during an early, routine, preventive visit: a prospective, randomized, open trial of 226 mother-infant pairs. Oral probiotics reduce the incidence and severity of necrotizing enterocolitis in very low birth weight infants. Multicentre trial of antepartum low-dose anti-D immunoglobulin. No beneficial effect of low-dose fetal intravenous gammaglobulin administration in combination with intravascular transfusions in severe Rh D haemolytic disease. A randomized, controlled trial of antepartum thyrotropin-releasing hormone and betamethasone in the prevention of respiratory disease in preterm infants. Postnatal peer counselling on exclusive breastfeeding of low-birthweight infants: a randomized, controlled trial. Use of a polyvalent bacterial lysate in patients with recurrent respiratory tract infections: results of a prospective, placebo-controlled, randomized, double-blind study. Use of surfactant for prophylaxis versus rescue treatment of respiratory distress syndrome: experience from an Italian-Bulgarian trial. Prevention of the HBsAg carrier state in newborn infants of mothers who are chronic carriers of HBsAg and HBeAg by administration of hepatitis-B vaccine and hepatitis-B immunoglobulin. Double-blind randomised placebo-controlled study. Effect of intervention to improve breastfeeding technique on the frequency of exclusive breastfeeding and lactation-related problems. Companionship to modify the clinical birth environment: effects on progress and perceptions of labour, and breastfeeding. A study of breastfeeding and the return of menses in Hoima District, Uganda. Direct observation of treatment for tuberculosis: a randomized controlled trial of community health workers versus family members. Multicenter study of the Lactational Amenorrhea Method (LAM): I. Efficacy, duration, and implications for clinical application. Santiago Breastfeeding Promotion Program: preliminary results of an intervention study. Pulmonary effects of triiodothyronine (T3) and hydrocortisone (HC) supplementation in preterm infants less than 30 weeks gestation: results of the THORN trial--thyroid hormone replacement in neonates. The Provo multicenter early high-frequency oscillatory ventilation trial: improved pulmonary and clinical outcome in respiratory distress syndrome. Zinc supplementation reduces the incidence of acute lower respiratory infections in infants and preschool children: a double-blind, controlled trial. [Educational intervention on breastfeeding promotion to the Family Health Program team]. Evaluation of a new highly purified pertussis vaccine in infants and children. Randomised controlled trial of training health visitors to identify and help couples with relationship problems following a birth. Pragmatic randomized trial of antenatal intervention to prevent post-natal depression by reducing psychosocial risk factors. Monetary incentives in primary health care and effects on use and coverage of preventive health care interventions in rural Honduras: cluster randomised trial. Comparative safety and immunogenicity of an acellular versus whole-cell pertussis component of diphtheria-tetanus-pertussis vaccines in Senegalese infants. Does routine home visiting improve the return rate and outcome of DOTS patients who delay treatment? Clinical, psychosocial, and economic effects of antenatal day care for three medical complications of pregnancy: a randomised controlled trial of 395 women. Tick-borne encephalitis: development of a paediatric vaccine. A controlled, randomized, double-blind and multicentre study.
Study conducted in a suburb of Cape Town, South Africa.
                Comparison of successful tuberculosis treatment outcome rates between self supervision, supervision by lay health worker (LHW), and supervision by clinic nurse.
                Open, randomised, controlled trial with intention-to-treat analysis.
                All groups (n = 156) achieved similar outcomes (LHW vs. clinic nurse: risk difference 17.2%, 95% confidence interval [CI] -0.1-34.5; LHW vs. self supervision 15%, 95%CI -3.7-33.6). New patients benefit from LHW supervision (LHW vs clinic nurse: risk difference 24.2%, 95%CI 6-42.5, LHW vs. self supervision 39.1%, 95%CI 17.8-60.3) as do female patients (LHW vs. clinic nurse 48.3%, 95%CI 22.8-73.8, LHW vs. self supervision 32.6%, 95%CI 6.4-58.7).
                LHW supervision approaches statistically significant superiority, but fails to reach it most likely due to the study's limitation, the small sample size. It is possible that subgroups (new and female patients) do well under LHW supervision. LHW supervision could be offered as one of several supervision options within TB control programmes. This pilot study investigated the feasibility of delivering a package of community-based interventions for improving perinatal care using lady health workers (LHWs) and traditional birth attendants (Dais) in rural Pakistan.
                The intervention was implemented in four of eight village clusters (315 villages, total population 138,600), while four served as a comparison group. The LHWs in intervention clusters received additional training focused on essential maternal and newborn care, conducted community education group sessions, and were encouraged to link up with local Dais. The intervention was delivered within the regular government LHW programme and was supported by the creation of voluntary community health committees.
                In intervention villages, there were significant reductions from baseline in stillbirth (from 65.9 to 43.1 per 1000 births, P < 0.001) and neonatal mortality rates (from 57.3 to 41.3 per 1000 live births, P < 0.001). The proportion of deliveries conducted by skilled attendants at public sector facilities also increased, from 18% at baseline to 30%, while the proportion of home births decreased from 79% to 65%. A household survey indicated a higher frequency of key behaviours (e.g. early and exclusive breastfeeding, delayed bathing and cord care) in intervention villages.
                The improved stillbirth and neonatal mortality rates observed indicate that community health workers (i.e. LHWs and Dais) can be effective in implementing a community and outreach package that leads to improved home care practices by families, increased care-seeking behaviour and greater utilization of skilled care providers. These preliminary observations require confirmation in an adequately powered trial. Interventions directed toward mothers before and during pregnancy and childbirth may help reduce preterm births and stillbirths. Survival of preterm newborns may also be improved with interventions given during these times or soon after birth. This comprehensive review assesses existing interventions for low- and middle-income countries (LMICs).
                Approximately 2,000 intervention studies were systematically evaluated through December 31, 2008. They addressed preterm birth or low birth weight; stillbirth or perinatal mortality; and management of preterm newborns. Out of 82 identified interventions, 49 were relevant to LMICs and had reasonable amounts of evidence, and therefore selected for in-depth reviews. Each was classified and assessed by the quality of available evidence and its potential to treat or prevent preterm birth and stillbirth. Impacts on other maternal, fetal, newborn or child health outcomes were also considered. Assessments were based on an adaptation of the Grades of Recommendation Assessment, Development and Evaluation criteria.
                Most interventions require additional research to improve the quality of evidence. Others had little evidence of benefit and should be discontinued. The following are supported by moderate- to high-quality evidence and strongly recommended for LMICs: Two interventions prevent preterm births--smoking cessation and progesterone. Eight interventions prevent stillbirths--balanced protein energy supplementation, screening and treatment of syphilis, intermittant presumptive treatment for malaria during pregnancy, insecticide-treated mosquito nets, birth preparedness, emergency obstetric care, cesarean section for breech presentation, and elective induction for post-term delivery. Eleven interventions improve survival of preterm newborns--prophylactic steroids in preterm labor, antibiotics for PROM, vitamin K supplementation at delivery, case management of neonatal sepsis and pneumonia, delayed cord clamping, room air (vs. 100% oxygen) for resuscitation, hospital-based kangaroo mother care, early breastfeeding, thermal care, and surfactant therapy and application of continued distending pressure to the lungs for respiratory distress syndrome
                The research paradigm for discovery science and intervention development must be balanced to address prevention as well as improve morbidity and mortality in all settings. This review also reveals significant gaps in current knowledge of interventions spanning the continuum of maternal and fetal outcomes, and the critical need to generate further high-quality evidence for promising interventions. This project aimed to evaluate the impact of a home visiting programme that targeted families where the child, for environmental reasons, was at great risk of poor health and developmental outcomes.
                Women in the immediate postpartum period were recruited to a randomized double-blind controlled trial on the basis of self-reported vulnerability factors and were randomly assigned to receive either a structured programme of nurse home visiting, supported by a social worker and paediatrician (n = 90), or assigned to a comparison group receiving standard community child health services (n = 91). Parenting stress and maternal depression were measured at enrollment and at 6 weeks. Preventive health behaviour, service satisfaction and home environment outcomes were tested at 6 weeks, as were child health outcomes.
                At six weeks, women receiving the home-based programme had significant reductions in postnatal depression screening scores as well as improvements in their experience of the parental role and improvement in the ability to maintain their own identity. Maternal-infant interactions were more likely to be positive, with significantly higher (better) scores in aspects of the home environment related to optimal development in children, particularly maternal-infant secure attachment. Intervention group mothers were significantly more satisfied with the community child health service.
                This form of intervention for families is effective in promoting secure maternal-infant attachment, preventing maternal mood disorder and is welcomed by the families receiving it. These findings may predict long-term benefits for the healthy development of children otherwise at risk of a range of poor health and development outcomes. Farms in the Boland health district, Western Cape Province, South Africa.
                To evaluate the effect of lay health workers (LHWs) on tuberculosis (TB) control among permanent farm workers and farm dwellers in an area with particularly high TB prevalence.
                Pragmatic, unblinded cluster randomised control trial.
                This trial measured successful treatment completion rates among new smear-positive (NSP) adult TB patients on 106 intervention farms, and compared them with outcomes in patients on 105 control farms. Farms were the unit of randomisation, and analysis was by intention to treat.
                A total of 164 adult TB patients were recruited into the study, 89 of whom were NSP. The successful treatment completion rate in NSP adult TB patients was 18.7% higher (P = 0.042, 95%CI 0.9-36.4) on farms in the intervention group than on farms in the control group. Case finding for adult NSP TB cases was 8% higher (P = 0.2671) on farms in the intervention group compared to the control group.
                Trained LHWs were able to improve the successful TB treatment rate among adult NSP TB patients in a well-established health service, despite reduction of services. Individual malaria interventions provide only partial protection in most epidemiological situations. Thus, there is a need to investigate whether combining interventions provides added benefit in reducing mortality and morbidity from malaria. The potential benefits of combining IPT in children (IPTc) with home management of malaria (HMM) was investigated.
                During the 2008 malaria transmission season, 1,277 children under five years of age resident in villages within the rural Farafenni demographic surveillance system (DSS) in North Bank Region, The Gambia were randomized to receive monthly IPTc with a single dose of sulphadoxine/pyrimethamine (SP) plus three doses of amodiaquine (AQ) or SP and AQ placebos given by village health workers (VHWs) on three occasions during the months of September, October and November, in a double-blind trial. Children in all study villages who developed an acute febrile illness suggestive of malaria were treated by VHWs who had been taught how to manage malaria with artemether-lumefantrine (Coartem™). The primary aims of the project were to determine whether IPTc added significant benefit to HMM and whether VHWs could effectively combine the delivery of both interventions.
                The incidence of clinical attacks of malaria was very low in both study groups. The incidence rate of malaria in children who received IPTc was 0.44 clinical attacks per 1,000 child months at risk while that for control children was 1.32 per 1,000 child months at risk, a protective efficacy of 66% (95% CI -23% to 96%; p = 0.35). The mean (standard deviation) haemoglobin concentration at the end of the malaria transmission season was similar in the two treatment groups: 10.2 (1.6) g/dL in the IPTc group compared to 10.3 (1.5) g/dL in the placebo group. Coverage with IPTc was high, with 94% of children receiving all three treatments during the study period.
                Due to the very low incidence of malaria, no firm conclusion can be drawn on the added benefit of IPTc in preventing clinical episodes of malaria among children who had access to HMM in The Gambia. However, the study showed that VHWs can successfully combine provision of HMM with provision of IPTc. Chronic obstructive pulmomary disease (COPD) is associated with substantial mortality, morbidity, and costs to the health care system. With the increasing interest in outreach care programmes it is important to evaluate their impact upon patients and health services, for conditions such as COPD.
                To determine the effectiveness of an outreach respiratory nurse in a shared care approach, with collaboration between general practitioners and hospital services, in the management of patients with severe COPD.
                Patients with severe COPD attending The Queen Elizabeth Hospital, Adelaide participated in a randomised controlled trial of a home based nursing intervention (HBNI) over 12 months with outcome measures including mortality rate, hospital service utilisation, FEV1 and health related quality of life (HRQL) using a modified Dartmouth Primary Care Co-operative Quality of Life questionnaire.
                There were 48 subjects in each study arm, with no differences in mortality rate (eight deaths in the HBNI group and seven in the control group), hospital admissions, length of stay, number of outpatient and Emergency Service visits. The study had inadequate follow-up of FEV1 and HRQL within the control group. Within the HBNI group, a small improvement in HRQL (in three of ten indices measured) was demonstrated, despite a deterioration in FEV1 (11% reduction, p=0.04) compared to baseline. Quality of life of HBNI subjects' carers did not change.
                An increased level of care given by an outreach respiratory nurse in a shared care approach for patients with severe COPD produced small improvements in HRQL but did not result in the prevention of deaths or reduced health care utilisation. The advantages of breastfeeding have been well established for both mothers and their infants. Existing research reports equivocal effects of early discharge and postpartum home care on breastfeeding success. The purpose of this study was to compare the effects of breastfeeding support offered in hospital and home settings on breastfeeding outcomes and maternal satisfaction for mothers of term and near-term newborns who experienced standard or early discharge.
                In a randomized controlled trial with prognostic stratification for gestational age, 101 term and 37 near-term (35-37 weeks' gestational age) mother-newborn pairs were randomized to either a standard care group (standard care and standard length of hospitalization) or an experimental group (standard hospital care with early discharge and home support from nurses who were certified lactation consultants). Data collection occurred before randomization, at discharge from hospital, and from 5 to 12 days postpartum. Primary outcomes included breastfeeding rates and maternal satisfaction.
                More mothers of term newborns in the experimental group were breastfeeding exclusively at follow-up (p = 0.02) compared with the control group. No significant breastfeeding differences occurred among mothers with near-term newborns in the experimental and standard care groups.
                In-home lactation support appears to facilitate positive breastfeeding outcomes for mothers of term newborns. This may also be a beneficial model of postpartum care for mothers of near-term newborns; however, further research is required. The findings suggest implications for health caregivers and policy makers with respect to postpartum lactation and health care services. Preterm newborns have low serum thyroxine (T4) levels compared with late-gestational fetuses. Low thyroid hormone levels are associated with increased severity of neonatal illness and neurodevelopmental dysfunction. We assessed the endocrine and clinical effects of increasing serum T4 levels in preterm newborns with a gestational age <31 wk. Forty newborns were randomized in a double blind protocol: 20 infants received a daily dose of 20 microg/kg L-T4 for 2 wk, whereas 20 control infants received saline. Serum concentrations of T4, triiodothyronine (T3), reverse T3 (rT3), thyroglobulin (TG), and TSH were measured weekly as well as serum levels of GH, prolactin, and IGF-I. After 2 wk, a TSH-releasing hormone (TRH) test was performed. Neonatal illness and outcome was evaluated by noting heart rate, oxygen requirement, duration of ventilation, development of chronic lung disease, oral fluid intake, and weight gain; a Bayley score was done at the corrected age of 7 mo. L-T4 administration induced a marked increase in serum T4 without apparent change in T3 levels, whereas the postnatal decline in serum rT3 was more gradual. L-T4 treatment was associated with a decrease in serum TG and TSH levels. TRH injection induced a definite rise in serum TSH and T3 in controls, but not in L-T4 treated newborns. Neither L-T4 treatment, nor TRH administration appeared to alter circulating levels of prolactin, GH, or IGF-I. In contrast to the pronounced endocrine effects, no clinical effects of L-T4 administration were detected. The Projahnmo-II Project in Mirzapur upazila (sub-district), Tangail district, Bangladesh, is promoting care-seeking for sick newborns through health education of families, identification and referral of sick newborns in the community by community health workers (CHWs), and strengthening of neonatal care in Kumudini Hospital, Mirzapur. Data were drawn from records maintained by the CHWs, referral hospital registers, a baseline household survey of recently-delivered women conducted from March to June 2003, and two interim household surveys in January and September 2005. Increases were observed in self-referral of sick newborns for care, compliance after referral by the CHWs, and care-seeking from qualified providers and from the Kumudini Hospital, and decreases were observed in care-seeking from unqualified providers in the intervention arm. An active surveillance for illness by the CHWs in the home, education of families by them on recognition of danger signs and counselling to seek immediate care for serious illness, and improved linkages between the community and the hospital can produce substantial increases in care-seeking for sick newborns. A randomized, double-blind, placebo-controlled community-based trial of oral iron supplementation (200 mg ferrous sulphate daily) administered to multigravid pregnant women by traditional birth attendants (TBAs) was carried out in a rural area of The Gambia. Iron supplementation led to a significant reduction in the prevalence of anaemia and of iron deficiency. Iron supplementation was not accompanied by increased susceptibility to malaria infection; there was no difference in the prevalence and severity of peripheral blood or placental malaria infection between the 2 groups of women. The birth weight of children born to women who received iron prophylaxis was increased by an average of 56 g. It is concluded that oral iron prophylaxis can be successfully delivered through TBAs integrated into a primary health care programme. This simple intervention can produce significant beneficial effects on the health of the mother without inducing increased susceptibility to malaria and has the potential for reducing perinatal mortality by increasing birth weight. The aim of the study was to compare the performance of midwives with that of lady home visitors (LHV; paraprofessionals). The project area was divided into six according to the population map. One midwife or one LHV was assigned to each visiting area. Home visits were carried out to identify and offer guidance on family planning (FP), antenatal care, well-child control, immunizations and other mother and child health related issues to those at high risk. Criteria taken for evaluation were the numbers of pregnant women identified in the last trimester; pregnant women receiving antenatal care; deliveries attended by a health care provider; modern FP users; continuation rate of the new users; pregnancy rate in new users; immunization status of children; well-child visits of the children. No significant differences were found in these health measurements between areas visited by LHV and areas visited by midwives. Response rates to the invitation was also similar in both areas. An important observation was the good performance of the LHV in communicating with the families. Women with limited school attainment from the community can be used effectively and efficiently in community health services. Current evidence that breastfeeding is beneficial for infant and child health is based exclusively on observational studies. Potential sources of bias in such studies have led to doubts about the magnitude of these health benefits in industrialized countries.
                To assess the effects of breastfeeding promotion on breastfeeding duration and exclusivity and gastrointestinal and respiratory infection and atopic eczema among infants.
                The Promotion of Breastfeeding Intervention Trial (PROBIT), a cluster-randomized trial conducted June 1996-December 1997 with a 1-year follow-up.
                Thirty-one maternity hospitals and polyclinics in the Republic of Belarus.
                A total of 17 046 mother-infant pairs consisting of full-term singleton infants weighing at least 2500 g and their healthy mothers who intended to breastfeed, 16491 (96.7%) of which completed the entire 12 months of follow-up.
                Sites were randomly assigned to receive an experimental intervention (n = 16) modeled on the Baby-Friendly Hospital Initiative of the World Health Organization and United Nations Children's Fund, which emphasizes health care worker assistance with initiating and maintaining breastfeeding and lactation and postnatal breastfeeding support, or a control intervention (n = 15) of continuing usual infant feeding practices and policies.
                Duration of any breastfeeding, prevalence of predominant and exclusive breastfeeding at 3 and 6 months of life and occurrence of 1 or more episodes of gastrointestinal tract infection, 2 or more episodes of respiratory tract infection, and atopic eczema during the first 12 months of life, compared between the intervention and control groups.
                Infants from the intervention sites were significantly more likely than control infants to be breastfed to any degree at 12 months (19.7% vs 11.4%; adjusted odds ratio [OR], 0.47; 95% confidence interval [CI], 0.32-0.69), were more likely to be exclusively breastfed at 3 months (43.3% vs 6.4%; P<.001) and at 6 months (7.9% vs 0.6%; P =.01), and had a significant reduction in the risk of 1 or more gastrointestinal tract infections (9.1% vs 13.2%; adjusted OR, 0.60; 95% CI, 0.40-0.91) and of atopic eczema (3.3% vs 6.3%; adjusted OR, 0.54; 95% CI, 0.31-0.95), but no significant reduction in respiratory tract infection (intervention group, 39.2%; control group, 39.4%; adjusted OR, 0.87; 95% CI, 0.59-1.28).
                Our experimental intervention increased the duration and degree (exclusivity) of breastfeeding and decreased the risk of gastrointestinal tract infection and atopic eczema in the first year of life. These results provide a solid scientific underpinning for future interventions to promote breastfeeding. To examine the influence of cotrimoxazole (CTM) prophylaxis on incidence of lower respiratory tract infections (LRTIs) and diarrhoea.
                A prospective observational cohort study. Morbidity and feeding data on infants born to HIV-infected mothers were collected routinely at clinic visits at 1 week, 6 weeks and 3 months, and 3-monthly thereafter, with blood drawn for determining HIV status.
                Two hospitals in Durban, South Africa. In one hospital (King Edward VIII Hospital), infants born to HIV infected mothers received CTM prophylaxis and in the other (McCord Hospital) infants did not receive CTM prophylaxis.
                Infants born to HIV-infected mothers. Outcome measures. Incidence of LRTI and diarrhoea.
                In multivariate analysis controlling for breast-feeding status, number of clinic visits and HIV infection status, HIV infected infants with access to CTM prophylaxis had a significantly lower incidence of LRTI (82%) than those without access to prophylaxis. However in HIV-uninfected infants, this was not the case. CTM prophylaxis was associated with a non-significant increased risk for diarrhea in both infected (odds ratio (OR) 1.58, p = 0.45) and uninfected infants (OR 1.52, p = 0.10).
                This observational study confirms current thinking that CTM prophylaxis is protective against LRTIs in HIV-infected children. However, because of a possible association between CTM prophylaxis and an increased risk of diarrhoea, HIV status of infants should be determined as early as possible in order to prevent unnecessary exposure of uninfected infants to CTM prophylaxis, while further studies to quantify both beneficial and adverse effects of CTM prophylaxis are undertaken. Pneumonia and malaria, two of the leading causes of morbidity and mortality among children under five in Zambia, often have overlapping clinical manifestations. Zambia is piloting the use of artemether-lumefantrine (AL) by community health workers (CHWs) to treat uncomplicated malaria. Valid concerns about potential overuse of AL could be addressed by the use of malaria rapid diagnostics employed at the community level. Currently, CHWs in Zambia evaluate and treat children with suspected malaria in rural areas, but they refer children with suspected pneumonia to the nearest health facility. This study was designed to assess the effectiveness and feasibility of using CHWs to manage nonsevere pneumonia and uncomplicated malaria with the aid of rapid diagnostic tests (RDTs).
                Community health posts staffed by CHWs were matched and randomly allocated to intervention and control arms. Children between the ages of 6 months and 5 years were managed according to the study protocol, as follows. Intervention CHWs performed RDTs, treated test-positive children with AL, and treated those with nonsevere pneumonia (increased respiratory rate) with amoxicillin. Control CHWs did not perform RDTs, treated all febrile children with AL, and referred those with signs of pneumonia to the health facility, as per Ministry of Health policy. The primary outcomes were the use of AL in children with fever and early and appropriate treatment with antibiotics for nonsevere pneumonia. A total of 3,125 children with fever and/or difficult/fast breathing were managed over a 12-month period. In the intervention arm, 27.5% (265/963) of children with fever received AL compared to 99.1% (2066/2084) of control children (risk ratio 0.23, 95% confidence interval 0.14-0.38). For children classified with nonsevere pneumonia, 68.2% (247/362) in the intervention arm and 13.3% (22/203) in the control arm received early and appropriate treatment (risk ratio 5.32, 95% confidence interval 2.19-8.94). There were two deaths in the intervention and one in the control arm.
                The potential for CHWs to use RDTs, AL, and amoxicillin to manage both malaria and pneumonia at the community level is promising and might reduce overuse of AL, as well as provide early and appropriate treatment to children with nonsevere pneumonia.
                ClinicalTrials.govNCT00513500 The addition of supplementary prenatal support may improve the health and well-being of high-risk women and families. The objective of this randomized controlled trial was to examine the impact of supplementary prenatal care on resource use among a community-based population of pregnant women.
                Pregnant women from three urban maternity clinics were randomized (a) to current standard of physician care, (b) to current standard of care plus consultation with a nurse, or (c) to (b) plus consultation with a home visitor. Participants were 1,352 women who received 3 telephone interviews. The primary outcome was resource use (e.g., attended prenatal classes, used nutritional counseling).
                Overall, those in the nurse intervention group were more likely to attend an "Early Bird" prenatal class and parenting classes, and to use nutrition counseling and agencies that assist with child care. Women provided with extra nursing and home visitation supports were more likely to use a written resource guide, nutrition counseling, and agencies that assist with child care. Among women at higher risk (e.g., language barriers, young maternal age, low income), the nurse intervention significantly increased use of early prenatal classes, whereas the nurse and home visitor intervention significantly increased use of the written resource guide and nutrition counseling. The intervention substantially increased the amount of information received on numerous pregnancy-related topics but had little impact on resource use for mental health and poverty-related needs. Among those with added support, resource use among low-risk women was generally greater than among high-risk women.
                Additional support provided by nurses, or nurses and home visitors, can successfully address informational needs and increase the likelihood that women will use existing community-based resources. This finding was true even for high-risk women, although this intervention did not reduce the difference in resource use between high- and low-risk women. To pilot test a newly developed breastfeeding self-efficacy intervention.
                Pilot randomized controlled trial (RCT).
                An acute care hospital located in Northwestern Ontario that is the sole provider of maternity care for the city and referral center for the region.
                One-hundred-and-fifty primiparous women intending to breastfeed their healthy, term, singleton infant.
                A standardized, individualized nursing intervention protocol was designed and administered to increase mothers' breastfeeding self-efficacy. Participants were randomly allocated to the intervention group or control group using sealed, opaque envelopes. Participants in the intervention group received three individualized, self-efficacy enhancing sessions with the researcher: two in-hospital and one by telephone. Participants in the control group received standard in-hospital and community care.
                Feasibility, compliance, and the acceptability of the breastfeeding self-efficacy intervention. Other outcomes assessed were breastfeeding self-efficacy, duration, and exclusivity.
                Findings suggest that the intervention was feasible; there was a high degree of protocol compliance, and the majority of mothers reported that the intervention was beneficial. Mothers in the intervention group had higher rates of breastfeeding self-efficacy, duration, and exclusivity at 4 and 8 weeks postpartum. However, the differences between groups were not statistically significant.
                The pilot RCT provided valuable information in examining the feasibility of the trial design and intervention.
                © 2011 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses. Malnutrition is common among children aged 6-24 months in developing countries. It increases the risk of mortality. Interventions to improve infant-feeding hold the promise of reducing malnutrition among these children. A study in Brazil has shown the success of training in communication and counselling skills among health workers in improving the nutritional status of young children. Questions were raised whether the method used in the study in Brazil would also be effective when applied in other countries. The aim of the present study was to reduce growth faltering in young children through proper nutrition-promotion techniques. The objective of the study was to determine the efficacy of training health workers in nutrition counselling in enhancing their communication skills and performance, improving feeding practices, and reducing growth faltering in children aged 6-24 months. A cluster-randomized controlled trial was carried out. The method used in this study was a replica of the method in a similar study in Pelotas, Brazil. Forty health centres were paired, and one centre of each pair was randomly allocated to the intervention group, and the other to the control group. The Integrated Management of Childhood Illness (IMCI) module-'Counsel the mother'-was used for training health workers in the health centres in the intervention group. Data from 36 paired health centres and 375 mothers and their children aged 6-24 months recruited from these health centres following consultation with health workers were included in analysis. Independent observers, masked to the intervention status, examined the performance of health workers within the first month after training. Mother-child pairs were visited at home within two weeks, 45 days, and 180 days after recruitment. Information was recorded on the feeding practices, recall of the recommendations of health workers, and sociodemographic variables at these home-visits. Weight and length of the child were measured at each contact. The communication skills and consultation performance of health workers were significantly better in the intervention group than in the control group. The mothers' recall of the recommendation of health workers and reported infant-feeding practices were also significantly better in the intervention group than in the control group, even 180 days after the recruitment consultation. Growth faltering was less in the intervention group, with the largest effect observed among children in the age-group of 12 + months. These results indicate that training in IMCI feeding counselling can enhance the communication skills and performance of health workers. Improved feeding practices of counselled mothers can, in turn, reduce growth faltering in their children. To assess whether adding a training intervention for clinic staff to the usual DOTS strategy (the internationally recommended control strategy for tuberculosis (TB)) would affect the outcomes of TB treatment in primary care clinics with treatment success rates below 70%.
                A cluster randomized controlled trial was conducted from July 1996 to July 2000 in nurse-managed ambulatory primary care clinics in Cape Town, South Africa. Clinics with successful TB treatment completion rates of less than 70% and annual adult pulmonary TB loads of more than 40 patients per year were randomly assigned to either the intervention (n = 12) or control (n = 12) groups. All clinics completed follow-up. Treatment outcomes were measured in cohorts of adult, pulmonary TB patients before the intervention (n = 1200) and 9 months following the training (n = 1177). The intervention comprised an 18-hour experiential, participatory in-service training programme for clinic staff delivered by nurse facilitators and focusing on patient centredness, critical reflection on practice, and quality improvement. The main outcome measure was successful treatment, defined as patients who were cured and those who had completed tuberculosis treatment.
                The estimated effect of the intervention was an increase in successful treatment rates of 4.8% (95% confidence interval (CI): -5.5% to 15.2%) and in bacteriological cure rates of 10.4% (CI: -1.2% to 22%). A treatment effect of 10% was envisaged, based on the views of policy-makers on the minimum effect size for large-scale implementation.
                This is the first evidence from a randomized controlled trial on the effects of experiential, participatory training on TB outcomes in primary care facilities in a developing country. Such training did not appear to improve TB outcomes. However, the results were inconclusive and further studies are required. To assess the impact of a supportive intervention on the duration of breastfeeding.
                A community based cluster-randomized trial in Western Denmark.
                Fifty-two health visitors and 781 mothers in the intervention group, and 57 health visitors and 816 mothers in the comparison group. Intervention: Health visitors in the intervention group received an 18-h course. The intervention addressed maternal psychosocial factors and consisted of 1-3 home visits during the first 5 weeks post-partum. Health visitors in the comparison group offered their usual practice. Main outcome measure: Duration of exclusive breastfeeding during 6 months of follow-up.
                Mothers in the intervention group had a 14% lower cessation rate (HR = 0.86 CI: 0.75-0.99). Similar results were seen for primipara, and multipara with previously short breastfeeding experience. Mothers in the intervention group received their first home visit earlier, had more visits and practical breastfeeding training within the first 5 weeks. Babies in the intervention group were breastfed more frequently, fewer used pacifiers, and their mothers reported more confidence in not knowing the exact amount of milk their babies had received when being breastfed.
                Home visits in the first 5 weeks following birth may prolong the duration of exclusive breastfeeding. Postnatal support should focus on both psychosocial and practical aspects of breastfeeding. Mothers with no or little previous breastfeeding experience require special attention. An estimated two-thirds of the world's 3.2 million stillbirths occur antenatally, prior to labour, and are often overlooked in policy and programs. Poorly recognised, untreated or inadequately treated maternal infections such as syphilis and malaria, and maternal conditions including hypertensive disorders, are known risk factors for stillbirth.
                We undertook a systematic review of the evidence for 16 antenatal interventions with the potential to prevent stillbirths. We searched a range of sources including PubMed and the Cochrane Library. For interventions with prior Cochrane reviews, we conducted additional meta-analyses including eligible newer randomised controlled trials following the Cochrane protocol. We focused on interventions deliverable at the community level in low-/middle-income countries, where the burden of stillbirths is greatest.
                Few of the studies we included reported stillbirth as an outcome; most that did were underpowered to assess this outcome. While Cochrane reviews or meta-analyses were available for many interventions, few focused on stillbirth or perinatal mortality as outcomes, and evidence was frequently conflicting. Several interventions showed clear evidence of impact on stillbirths, including heparin therapy for certain maternal indications; syphilis screening and treatment; and insecticide-treated bed nets for prevention of malaria. Other interventions, such as management of obstetric intrahepatic cholestasis, maternal anti-helminthic treatment, and intermittent preventive treatment of malaria, showed promising impact on stillbirth rates but require confirmatory studies. Several interventions reduced known risk factors for stillbirth (e.g., anti-hypertensive drugs for chronic hypertension), yet failed to show statistically significant impact on stillbirth or perinatal mortality rates. Periodontal disease emerged as a clear risk factor for stillbirth but no interventions have reduced stillbirth rates.
                Evidence for some newly recognised risk factors for stillbirth, including periodontal disease, suggests the need for large, appropriately designed randomised trials to test whether intervention can minimise these risks and prevent stillbirths. Existing evidence strongly supports infection control measures, including syphilis screening and treatment and malaria prophylaxis in endemic areas, for preventing antepartum stillbirths. These interventions should be incorporated into antenatal care programs based on attributable risks and burden of disease. Breastfeeding can ameliorate some of the complex health issues faced by low-income families. Women who breastfeed and their infants have lower health care costs compared with those who formula feed. Increasing the duration of breastfeeding is recognized as a national priority, particularly for low-income women. This community-based randomized clinical trial involving low-income mothers compared usual care with an intervention comprising hospital and home visits, and telephone support by a community health nurse/peer counselor team for 6 months after delivery.
                Forty-one women were recruited after delivery of a full-term singleton infant and randomly assigned to intervention or usual care groups.
                Women receiving the community health intervention breastfed longer than the women receiving usual care. The infants in the intervention group had fewer sick visits and reported use of fewer medications than infants in the usual care group. The intervention cost ($301/mother) was partially offset by cost savings on formula and health care.
                Community health nurse and peer counselor support can increase breastfeeding duration in low-income women, and has the potential to reduce total costs including the cost of support. Umbilical cord infection (omphalitis) is a risk factor for neonatal sepsis and mortality in low-resource settings where home deliveries are common. We aimed to assess the effect of umbilical-cord cleansing with 4% chlorhexidine (CHX) solution, with or without handwashing with antiseptic soap, on the incidence of omphalitis and neonatal mortality.
                We did a two-by-two factorial, cluster-randomised trial in Dadu, a rural area of Sindh province, Pakistan. Clusters were defined as the population covered by a functional traditional birth attendant (TBA), and were randomly allocated to one of four groups (groups A to D) with a computer-generated random number sequence. Implementation and data collection teams were masked to allocation. Liveborn infants delivered by participating TBAs who received birth kits were eligible for enrolment in the study. One intervention comprised birth kits containing 4% CHX solution for application to the cord at birth by TBAs and once daily by family members for up to 14 days along with soap and educational messages promoting handwashing. One intervention was CHX solution only and another was handwashing only. Standard dry cord care was promoted in the control group. The primary outcomes were incidence of neonatal omphalitis and neonatal mortality. The trial is registered with ClinicalTrials.gov, number NCT00682006.
                187 clusters were randomly allocated to one of the four study groups. Of 9741 newborn babies delivered by participating TBAs, factorial analysis indicated a reduction in risk of omphalitis with CHX application (risk ratio [RR]=0·58, 95% CI 0·41-0·82; p=0·002) but no evidence of an effect of handwashing (RR=0·83, 0·61-1·13; p=0·24). We recorded strong evidence of a reduction in neonatal mortality in neonates who received CHX cleansing (RR=0·62, 95 % CI 0·45-0·85; p=0·003) but no evidence of an effect of handwashing promotion on neonatal mortality (RR=1·08, 0·79-1·48; p=0·62). We recorded no serious adverse events.
                Application of 4% CHX to the umbilical cord was effective in reducing the risk of omphalitis and neonatal mortality in rural Pakistan. Provision of CHX in birth kits might be a useful strategy for the prevention of neonatal mortality in high-mortality settings.
                The United States Agency for International Development.
                Copyright Â© 2012 Elsevier Ltd. All rights reserved. Because resources for care of low-birthweight (LBW) infants in developing countries are scarce, the Kangaroo mother method (KMM) was developed. The infant is kept upright in skin-to-skin contact with the mother's breast. Previous studies reported several benefits with the KMM but interpretation of their findings is limited by small size and design weaknesses. We have done a longitudinal, randomised, controlled trial at the Isidro Ayora Maternity Hospital in Quito, Ecuador. Infants with LBW (< 2000 g) who satisfied out-of-risk criteria of tolerance of food and weight stabilisation were randomly assigned to KMM and control (standard incubator care) groups (n = 128 and 147, respectively). During 6 months of follow-up the KMM group had a significantly lower rate than the control group of serious illness (lower-respiratory-tract disorders, apnoea, aspiration, pneumonia, septicaemia, general infections; 7 [5%] vs 27 [18%], p < 0.002), although differences between the groups in less severe morbidity were not significant. There was no significant difference in growth or in the proportion of women breastfeeding, perhaps because the proportion breastfeeding was high in both groups owing to strong promotion. Mortality was the same in both groups; most deaths occurred during the stabilisation period before randomisation. KMM mothers made more unscheduled clinic visits than control mothers but their infants had fewer re-admissions and so the cost of care was lower with the KMM. Since the eligibility criteria excluded nearly 50% of LBW infants from the study, the KMM is not universally applicable to these infants. The benefits might be greater in populations where breastfeeding is not so common. Tuberculosis (TB) often coincides with nutritional deficiencies. The effects of micronutrient supplementation on TB treatment outcomes, clinical complications, and mortality are uncertain.
                We conducted a randomized, double-blind, placebo-controlled trial of micronutrients (vitamins A, B complex, C, and E, as well as selenium) in Dar es Salaam, Tanzania. We enrolled 471 human immunodeficiency virus (HIV)-infected and 416 HIV-negative adults with pulmonary TB at the time of initiating chemotherapy and monitored them for a median of 43 months.
                Micronutrients decreased the risk ofTB recurrence by 45% overall (95% confidence interval [CI], 7% to 67%; P = .02) and by 63% in HIV-infected patients (95% CI, 8% to 85%; P = .02). There were no significant effects on mortality overall; however, we noted a marginally significant 64% reduction of deaths in HIV-negative subjects (95% CI, -14% to 88%; P = .08). Supplementation increased CD3+ and CD4+ cell counts and decreased the incidence of extrapulmonary TB and genital ulcers in HIV-negative patients. Micronutrients reduced the incidence of peripheral neuropathy by 57% (95% CI, 41% to 69%; P < .001), irrespective of HIV status. There were no significant effects on weight gain, body composition, anemia, or HIV load.
                Micronutrient supplementation could improve the outcome in patients undergoing TB chemotherapy in Tanzania. To assess the effect of micronutrient supplementation on tuberculosis (TB) patient outcomes.
                The randomized, double-blinded, placebo-controlled study was conducted in pulmonary TB patients undergoing directly observed treatment short course/ tratamiento acortado estrictamente supervisado (TAES/ DOTS) at IMSS in Ciudad Juarez, Chihuahua, Mexico, who were recruited during August 2005-July 2006. Consecutive patients received zinc and vitamin A supplements or matched placebo for four months. Dietary intake, blood zinc and vitamin A, immune response (IFN-gamma,TNF-alpha, and IL-10 mRNA), and sputum smear conversion were measured.
                The proportion of micronutrient compared to placebo group subjects with a negative sputum smear by month 3 was significantly increased (p= 0.03). This occurred subsequent to increased TNF-alpha and IFN-gamma and decreased IL-10 observed at month 2. Micronutrient supplementation appeared to accelerate the beneficial therapeutic effect of chemotherapy.
                The earlier elimination of bacilli from sputum was associated with improved zinc status and Th1 immune response. The therapeutic effect of vitamin A was less evident. The aim of the study was to assess the effects of micronutrient supplementation on culture conversion in tuberculosis (TB) patients.
                The study was a randomized, double-blind placebo-controlled 2 x 2 trial of zinc and multi-micronutrient (MMN) supplementation in pulmonary TB patients in Tanzania.
                A total of 499 pulmonary TB patients were included in the trial after being confirmed sputum-positive by microscopy or culture. At 8 weeks, 25% were sputum-smear positive but only 11% were culture-positive (P<0.0001). No significant differences were observed in culture conversion rate among those allocated to MMN or placebo (89.5 vs. 86.2%, P=0.29) at 8 weeks, although at week 4 those allocated to MMN had a slightly reduced culture conversion rate (42.8 vs. 52.8%, P=0.058). Zinc had no effects on culture conversion. MMN increased weight gain by 0.78 kg [95% confidence interval (CI): 0.12--1.43] at week 8, while zinc supplementation had no effect. The effects of MMN and zinc did not interact and neither MMN nor zinc interacted with human immunodeficiency virus status, sex and culture-intensity at baseline.
                Neither zinc nor MMN supplementation had significant effects on culture conversion, but MMN supplementation increased weight gain in TB patients. The purpose of this study was to determine the feasibility and acceptability of kangaroo care in a tertiary care hospital in India.
                A randomized controlled trial was performed over one year period in which 89 neonates were randomized into two groups kangaroo mother care (KMC) and conventional method of care (CMC).
                Forty-four babies were randomized into KMC group and 45 to CMC. There was significant reduction in KMC vs CMC group of hypothermia (10/44 vs 21/45, p-value < 0.01), higher oxygen saturations (95.7 vs 94.8%, p-value < 0.01) and decrease in respiratory rates (36.2 vs 40.7, p-value < 0.01). There were no statistically significant differences in the incidence of hyperthermia, sepsis, apnea, onset of breastfeeding and hospital stay in two groups. 79% of mothers felt comfortable during the KMC and 73% felt they would be able to give KMC at home. KMC is feasible, as mothers are already admitted in hospitals and are involved in the care of newborn.
                KMC is a simple and feasible intervention; acceptable to most mothers admitted in hospitals. There may be benefits in terms of reducing the incidence of hypothermia with no adverse effects of KMC demonstrated in the study. The present study has important implications in the care of LBW infants in the developing countries, where expensive facilities for conventional care may not be available at all place. The nature of hypothyroxinemia in sick very low-birth-weight (VLBW) infants was evaluated by assessment of the hypothalamic-pituitary axis and by the clinical response to thyroxine (T4) therapy. Twenty-three very low-birth-weight infants of gestational age 26 to 28 weeks, whose serum T4 concentrations were 4 micrograms/dL on two occasions, and thyrotropin less than 20 microU/mL, were included in a double-blind study. Following a thyrotropin-releasing hormone stimulation test, babies were given either T4 or placebo. Nine babies were thyrotropin-releasing hormone tested prior to therapy; four babies, two from each group, were tested 1 to 2 weeks after therapy. In 11 untreated babies, mean base line serum thyrotropin of 7.0 +/- 1.4 rose to 23.7 +/- 4.1 microU/mL in 30 minutes. This response was not significantly greater than the observed response in full-term babies, 23.7 +/- 4.1 v 16.6 +/- 0.97 microU/mL, respectively, P greater than .05. In two babies treated with T4 the thyrotropin response to thyrotropin-releasing hormone was completely suppressed. Serial serum T4 determinations showed normalization in both groups after a similar time interval. There was no beneficial effect of T4 therapy on growth of head circumference, length, or weight. Developmental data revealed no significant differences in the mental, motor, or gross neurologic outcome in the treated and nontreated infants after 1 year of follow-up. These observations imply that hypothyroxinemia in sick preterm infants is not a direct consequence of hypothyroidism. Despite the lack of demonstrable short-term beneficial effects of T4 therapy, follow-up studies are necessary to resolve the question of long-term benefits. Interest in home-visitation services as a way of improving maternal and child outcomes has grown out of the favorable results of a trial in semirural New York. The findings have not been replicated in other populations.
                To test the effect of prenatal and infancy home visits by nurses on pregnancy-induced hypertension, preterm delivery, and low birth weight; on children's injuries, immunizations, mental development, and behavioral problems; and on maternal life course.
                Randomized controlled trial.
                Public system of obstetric care in Memphis, Tenn.
                A total of 1139 primarily African-American women at less than 29 weeks' gestation, with no previous live births, and with at least 2 sociodemographic risk characteristics (unmarried, <12 years of education, unemployed).
                Nurses made an average of 7 (range, 0-18) home visits during pregnancy and 26 (range, 0-71) visits from birth to the children's second birthdays.
                Pregnancy-induced hypertension, preterm delivery, low birth weight, children's injuries, ingestions, and immunizations abstracted from medical records; mothers' reports of children's behavioral problems; tests of children's mental development; mothers' reports of subsequent pregnancy, educational achievement, and labor-force participation; and use of welfare derived from state records.
                In contrast to counterparts assigned to the comparison condition, fewer women visited by nurses during pregnancy had pregnancy-induced hypertension (13% vs 20%; P=.009). During the first 2 years after delivery, women visited by nurses during pregnancy and the first 2 years of the child's life had fewer health care encounters for children in which injuries or ingestions were detected (0.43 vs 0.55; P=.05); days that children were hospitalized with injuries or ingestions (0.03 vs 0.16; P<.001); and second pregnancies (36% vs 47%; P=.006). There were no program effects on preterm delivery or low birth weight; children's immunization rates, mental development, or behavioral problems; or mothers' education and employment.
                This program of home visitation by nurses can reduce pregnancy-induced hypertension, childhood injuries, and subsequent pregnancies among low-income women with no previous live births. Evaluating complex interventions in health services faces various difficulties, such as making practice changes and costs. Ways to increase research capacity and decrease costs include making research an integral part of health services and using routine data to judge outcomes. The purpose of this article is to report the feasibility of a pilot trial relying solely on routinely collected register data and being based on ordinary health services.
                The example intervention was education to public health nurses (PHN) (childbirth classes) to reduce caesarean section rates via pre-delivery considerations of pregnant women. 20 maternity health centers (MHC) were paired and of each 10 pairs, one MHC was randomly allocated to an intervention group and the other to a control; 8 pairs with successful intervention were used in the analyses (1601 mothers). The women visiting to the study maternity centers were identified from the Customer Register of Helsinki City. A list of the study women was made using the mother's personal identification number, visit date, the maternity center code, birth date and gestation length. The mode of delivery and health outcomes were retrieved from the Finnish Medical Birth Register (MBR). Process data of the intervention are based on observations, written feedback and questionnaires from PHNs, and project correspondence.
                It took almost two years to establish how to obtain permissions and to actually obtain it for the trial. Obtaining permissions for the customer and outcome data and register linkages was unproblematic and the cluster randomization provided comparable groups. The intervention did not succeed well. Had the main aim of the trial been to cause a change in PHNs behavior, we would have very likely intensified the intervention during the trial.
                Our experiences encourage the use of trials that obtain their outcomes from registers. Changing the behavior of ordinary health service providers is a challenging intervention.
                not registered (see Results). The vast majority of global stillbirths occur in low- and middle-income countries, and in many settings, the majority of stillbirths occur antenatally, prior to the onset of labour. Poor nutritional status, lack of antenatal care and a number of behaviours increase women's risk of stillbirth in many resource-poor settings. Interventions to reduce these risks could reduce the resulting burden of stillbirths, but the evidence for the impact of such interventions has not yet been comprehensively evaluated.
                This second paper of a systematic review of interventions that could plausibly impact stillbirth rates covers 12 different interventions relating to behavioural and socially mediated risk factors, including exposures to harmful practices and substances, antenatal care utilisation and quality, and maternal nutrition before and during pregnancy. The search strategy reviewed indexed medical journals on PubMed and the Cochrane Library. If any eligible randomised controlled trials were identified that were published after the most recent Cochrane review, they were added to generate new meta-analyses. Interventions covered in this paper have a focus on low- and middle-income countries, both because of the large burden of stillbirths and because of the high prevalence of risk factors including maternal malnutrition and harmful environmental exposures. The reviews and studies belonging to these interventions were graded and conclusions derived about the evidence of benefit of these interventions.
                From a programmatic perspective, none of the interventions achieved clear evidence of benefit. Evidence for some socially mediated risk factors were identified, such as exposure to indoor air pollution and birth spacing, but still require the development of appropriate interventions. There is a need for additional studies on culturally appropriate behavioural interventions and clinical trials to increase smoking cessation and reduce exposure to smokeless tobacco. Balanced protein-energy supplementation was associated with reduced stillbirth rates, but larger well-designed trials are required to confirm findings. Peri-conceptional folic acid supplementation significantly reduces neural tube defects, yet no significant associated reductions in stillbirth rates have been documented. Evidence for other nutritional interventions including multiple micronutrient and Vitamin A supplementation is weak, suggesting the need for further research to assess potential of nutritional interventions to reduce stillbirths.
                Antenatal care is widely used in low- and middle-income countries, and provides a natural facility-based contact through which to provide or educate about many of the interventions we reviewed. The impact of broader socially mediated behaviors, such as fertility decision-making, access to antenatal care, and maternal diet and exposures like tobacco and indoor air pollution during pregnancy, are poorly understood, and further research and appropriate interventions are needed to test the association of these behaviours with stillbirth outcomes. For most nutritional interventions, larger randomised controlled trials are needed which report stillbirths disaggregated from composite perinatal mortality. Many antepartum stillbirths are potentially preventable in low- and middle-income countries, particularly through dietary and environmental improvement, and through improving the quality of antenatal care - particularly including diagnosis and management of high-risk pregnancies - that pregnant women receive. In New South Wales, health screening of school entrants provides the only mechanism for routine monitoring of immunisation uptake in children. School health nurses are in the best position to improve the compliance with immunisation at this age. We compared two interventions to be used by the nurses to increase immunisation uptake in school entrants who reported missing either the measles-mumps vaccine and/or the pre-school diphtheria-tetanus toxoid and oral polio vaccine boosters. Parents in the passive intervention group were sent a letter and leaflet encouraging immunisation; the active intervention group received a telephone reminder from the nurse in addition to the written materials. Both groups were followed up at a later date to assess final immunisation outcome. Of 817 children screened, 88.2% had been immunised against measles and 73.6% had received the booster; 239 children were randomised to the two interventions. Excluding children lost to follow up and those fully immunised at the start of the study, 20 (37%) of 54 were immunised following the passive intervention, and 35 (71%) out of 49 following the active intervention (P = 0.001). Receipt of the letter and leaflet was associated with an increased uptake of booster vaccination (P = 0.036). The active intervention required 14.7 telephone calls and 1.6 uses of the interpreter service per completed immunisation. The passive intervention resulted in worthwhile increases in immunisation rate with minimum cost. A greater improvement in immunisation outcome was achieved by the active intervention, but its use was labour intensive and may only be warranted if high immunisation rates in this age-group are given priority. Neonatal mortality accounts for a high proportion of deaths in children under the age of 5 years in Bangladesh. Therefore the project for advancing the health of newborns and mothers (Projahnmo) implemented a community-based intervention package through government and non-government organisation infrastructures to reduce neonatal mortality.
                In Sylhet district, 24 clusters (with a population of about 20 000 each) were randomly assigned in equal numbers to one of two intervention arms or to the comparison arm. Because of the study design, masking was not feasible. All married women of reproductive age (15-49 years) were eligible to participate. In the home-care arm, female community health workers (one per 4000 population) identified pregnant women, made two antenatal home visits to promote birth and newborn-care preparedness, made postnatal home visits to assess newborns on the first, third, and seventh days of birth, and referred or treated sick neonates. In the community-care arm, birth and newborn-care preparedness and careseeking from qualified providers were promoted solely through group sessions held by female and male community mobilisers. The primary outcome was reduction in neonatal mortality. Analysis was by intention to treat. The study is registered with ClinicalTrials.gov, number 00198705.
                The number of clusters per arm was eight. The number of participants was 36059, 40159, and 37598 in the home-care, community-care, and comparison arms, respectively, with 14 769, 16 325, and 15 350 livebirths, respectively. In the last 6 months of the 30-month intervention, neonatal mortality rates were 29.2 per 1000, 45.2 per 1000, and 43.5 per 1000 in the home-care, community-care, and comparison arms, respectively. Neonatal mortality was reduced in the home-care arm by 34% (adjusted relative risk 0.66; 95% CI 0.47-0.93) during the last 6 months versus that in the comparison arm. No mortality reduction was noted in the community-care arm (0.95; 0.69-1.31).
                A home-care strategy to promote an integrated package of preventive and curative newborn care is effective in reducing neonatal mortality in communities with a weak health system, low health-care use, and high neonatal mortality. To investigate the effects of nutritional supplementation on the outcome and nutritional status of south Indian patients with tuberculosis (TB) with and without human immunodeficiency virus (HIV) coinfection on anti-tuberculous therapy.
                Randomized controlled trial on the effect of a locally prepared cereal-lentil mixture providing 930 kcal and a multivitamin micronutrient supplement during anti-tuberculous therapy in 81 newly diagnosed TB alone and 22 TB-HIV-coinfected patients, among whom 51 received and 52 did not receive the supplement. The primary outcome evaluated at completion of TB therapy was outcome of TB treatment, as classified by the national programme. Secondary outcomes were body composition, compliance and condition on follow-up 1 year after cessation of TB therapy and supplementation.
                There was no significant difference in TB outcomes at the end of treatment, but HIV-TB coinfected individuals had four times greater odds of poor outcome than those with TB alone. Among patients with TB, 1/35 (2.9%) supplemented and 5/42(12%) of those not supplemented had poor outcomes, while among TB-HIV-coinfected individuals, 4/13 (31%) supplemented and 3/7 (42.8%) non-supplemented patients had poor outcomes at the end of treatment, and the differences were more marked after 1 year of follow-up. Although there was some trend of benefit for both TB alone and TB-HIV coinfection, the results were not statistically significant at the end of TB treatment, possibly because of limited sample size.
                Nutritional supplements in patients are a potentially feasible, low-cost intervention, which could impact patients with TB and TB-HIV. The public health importance of these diseases in resource-limited settings suggests the need for large, multi-centre randomized control trials on nutritional supplementation.
                © 2011 Blackwell Publishing Ltd. To evaluate the role of recombinant human erythropoietin (R-HuEpo) in reducing iron infusion, which may exacerbate free radical damage, leading to chronic lung disease.
                A multicentre, randomised, placebo controlled, double blind study was carried out in four neonatal intensive care units in Yorkshire. Infants were randomly allocated and received either R-HuEpo (480 U/kg/wk) or placebo by twice weekly subcutaneous injection. The primary outcome measure was the number of days on respiratory support and a secondary outcome the number of blood transfusions required.
                Forty two very low birthweight (VLBW) infants were randomly allocated. There was little difference in the need for respiratory support one month after randomisation, but subsequently there was a trend towards a reduction in the proportion requiring respiratory support in the R-HuEpo group (difference at three months -0.50, 95% confidence interval -1.00, 0.17). During stay in hospital, the median number of blood transfusions was lower for infants in the R-HuEpo group (difference in medians -2, 95% CI -4, 0). The study was stopped early because of failure to recruit babies at the expected rate.
                R-HuEpo seems to reduce the number of days in oxygen for ill VLBW infants. These data could be used to construct a larger multicentre study to evaluate this effect further. In a randomized, controlled trial in five regional centers with state health department clinics, 1458 women at high risk for low birth weight (LBW) outcome received either prenatal interventions provided by nurse-midwives and nurses under their supervision or the standard high-risk prenatal care provided by obstetricians. The intervention administered by the nurse-midwives included patient education to identify the signs and symptoms of preterm labor, activity counseling in response to monitoring of the cervix by frequent examinations, stress reduction by enhancing social support, nutrition counseling with emphasis on weight gain, and substance-abuse counseling. For women in the control group, care was provided by obstetricians according to local standards for the management of high-risk pregnancies. We hypothesized that the LBW rate among live births to women who had received care from nurse-midwives would be lower than that in the control group. Although the LBW rate was lower in the intervention group than in the control group, the observed difference was not statistically significant. Race was not prespecified as a possible effect modifier, but examination of the data post hoc suggested that black women at high statistical risk of giving birth to an LBW infant may have derived benefit from the program. Although the results do not suggest any striking advantage of the nurse-midwifery intervention over standard obstetric care for women at high statistical risk of having an LBW infant, neither do they suggest any disadvantage. Nurse-midwives could provide care to certain populations of high-risk women and facilitate future coverage of these presently underserved populations. To evaluate the effectiveness of a training program for care providers in improving practice of essential newborn care in obstetric units.
                Before-and-after study with an intervention and a control group.
                Five hospitals in the Puttalam district in Sri Lanka.
                Eight hundred and ninety-two mother-newborn pairs (446 before and 446 three months after).
                A 4-day training program on essential newborn care for doctors, nurses, and midwives of the obstetric units in two hospitals.
                By direct observation, practices of essential newborn care at delivery in the labor room on a subsample. By interviewing mothers, immediate skin-to-skin contact and early initiation of breastfeeding. From health records, "undesirable health events" of the newborns.
                Practices of cleanliness, thermal protection, and neonatal assessment improved significantly in the intervention group. The intervention was effective in improving skin-to-skin contact by 1.5 times and early initiation of breastfeeding by 3.4 times. Undesirable health events declined from 32 to 21 per 223 newborns in the intervention group and from 20 to 17 per 223 newborns in the control group.
                A comprehensive 4-day training program can be followed by a significant improvement in essential newborn care practices in obstetric units. To assess the impact of a voluntary, paraprofessional home visiting program on promoting child health and development and maternal parenting knowledge, attitudes, and behaviors.
                This collaborative, experimental study of 6 Healthy Families Alaska (HFAK) programs enrolled 325 families from 1/00 to 7/01, randomly assigned them to HFAK and control groups, interviewed mothers at baseline, and followed families until children were 2 years old (85% follow-up). Child outcomes included health care use, development and behavior. Parent outcomes included knowledge of infant development, parenting attitudes, quality of the home environment, and parent-child interaction. HFAK records were reviewed to measure home visiting services. Home visitors were surveyed to measure knowledge, perceived effectiveness and perceived training adequacy.
                There was no overall impact on child health, but HFAK group children had more favorable developmental and behavioral outcomes. HFAK and control mothers had similar parenting outcomes except that HFAK mothers had greater parenting self-efficacy (35.1 vs. 34.6 based on the Teti Self-Efficacy Scale, p<.05). Fewer HFAK families had a poor home environment for learning (20% vs. 31%, p<.001). HFAK families were more likely to use center-based parenting services (48% vs. 39%, p<.05). The impact was greater for families with lower baseline risk (Family Stress Checklist scores<45). There was little evidence of efficacy for families with a higher dose of service.
                The program promoted child development and reduced problem behaviors at 2 years. Impact could be strengthened by improving home visitor effectiveness in promoting effective parenting. Future research is needed to determine whether short-term benefits are sustained. Transient hypothyroxinemia in premature newborns has been linked with poor neonatal outcomes. We designed this study to evaluate the effects of early thyroxine (T4) administration in the premature infant.
                A total of 49 newborns less than 32 weeks' gestation, were randomized in a double-blind, placebo-controlled trial. Within the first 48 hours of life, T4 (10 or 20 micrograms/kg; intravenous or through nasogastric tube, respectively) was administered for a total of 21 days. Chronic lung disease, the primary outcome variable, was defined by oxygen dependency at 28 days of life.
                The incidence of chronic lung disease, death, grade III or IV intraventricular hemorrhage, periventricular leukomalacia, and sepsis was not different in the placebo and treated groups.
                Early T4 supplementation in preterm newborns less than 32 weeks' gestation does not decrease the incidence of chronic lung disease or other complications of prematurity. Healthy Steps (HS) was designed to address, prospectively, behavioral and developmental support needs of young families in pediatric clinical care settings. PrePare (PP) initiates these services prenatally, whereas HS begins services in the postnatal period. Both interventions have universal and risk-directed components. Intervention effects in the first 3 months after birth are reported here.
                A quasi-experimental design was used to allocate 439 participants to intervention or usual care conditions. Within the intervention group, enrollees were randomly assigned to receive HS or PP+HS services. Early outcomes were assessed by telephone survey at 1 week and 3 months postpartum.
                Mothers in either intervention condition were less likely to report depressive symptoms and more likely to describe themselves as pleased in their role as parents. Intervention families were more likely to continue breastfeeding and more likely to read to their 3-month-old. Knowledge of infant development and recognition of appropriate discipline was greater among intervention recipients. Satisfaction with pediatric care was higher among intervention recipients and the rate of health plan disenrollment was 75% lower at 3 months among those enrolled in the prenatal intervention. No other outcome difference emerged between HS and PP+HS enrollees.
                Receipt of either intervention was associated with positive effects on health, safety, and developmentally appropriate parenting, as assessed in early infancy. There were positive effects on health plan disenrollment. No additional benefit could be ascribed to prenatal institution of services. A combination of universal and risk-based support for new parents is recommended, rather than the provision of risk-based services alone. Parents of children with chronic illnesses are at high risk for secondary mental health problems, such as anxiety and depression.
                To evaluate maternal outcomes of a support intervention for families of children with selected chronic illnesses.
                A randomized controlled clinical trial design with repeated measures 1 year apart.
                A community-based family support intervention linked to subspecialty and general pediatric clinics and practices in a metropolitan area.
                A population-based sample of 193 mothers of children aged 7 to 11 years; the children were diagnosed as having diabetes, sickle cell anemia, cystic fibrosis, or moderate to severe asthma. About 15% of the persons contacted refused to participate in the research, and 14% of the families were lost to follow-up.
                The 15-month intervention, the Family-to-Family Network, was designed to enhance mothers' mental health by linking mothers of school-aged children with selected chronic illnesses with mothers of older children with the same condition. The program included telephone contacts, face-to-face visits, and special family events.
                Beck Depression Inventory score and the Psychiatric Symptom Index.
                Maternal anxiety scores for participants in the experimental group decreased during the intervention period for all diagnostic groups and for the total group; scores for the control group increased (F = 5.07, P =.03). In multiple regression analyses, the intervention group was a significant predictor of posttest anxiety scores (P =.03). Effects were greater for mothers with high baseline anxiety (P<.001) and for those who were themselves in poor health (P<.01).
                A family support intervention can have beneficial effects on the mental health status of mothers of children with chronic illnesses. This type of intervention can be implemented in diverse pediatric settings. Although widely practiced for over 80 years, the role of specific immunotherapy (SIT) in pediatric asthma treatment is still controversial. We assessed the effects of a 3-year period of subcutaneous administration of a standardized preparation of Dermatophagoides pteronyssinus (D pt) on the respiratory health in a group of asthmatic children monosensitized to house dust mite (HDM).
                A randomized clinical trial was performed after 1-year run-in period. Fifteen children receiving SIT for HDM and 14 controls (four drop-outs), matched for age, allergen sensitization, asthma severity, lung function, and non-specific bronchial reactivity (BHR), were studied during the 3-year treatment period. During the whole trial, respiratory symptoms, pharmacological and respiratory function parameters were regularly evaluated. Skin prick tests and methacholine challenge were performed at the beginning and end of the study.
                In the SIT group significant improvement in asthmatic symptoms and marked reduction in drug intake was observed. The SIT group also showed a significant decrease in non-specific bronchial BHR. No new sensitivity occurred during the study period in the SIT group only. No major local or systemic side-effects were reported during the study.
                Our results confirm that SIT is effective in asthmatic children sensitive to mites. It is associated with a decrease in BHR and it may prevent the development of new sensitizations in monosensitized subjects. To evaluate the efficacy of an early home-based intervention on the quality of maternal-infant attachment, maternal mood and child health parameters in a cohort of vulnerable families.
                A total of 181 families were recruited to the study in the immediate postnatal period on the basis of a self report questionnaire relating to known family vulnerability factors. Families were assigned randomly to intervention (90), or control (91) groups. The intervention group received a series of home visits from a child health nurse (weekly to 6 weeks, fortnightly to 3 months), with a subgroup receiving home based short-term dynamic therapy from a social worker. Parent/family function was assessed at inception and at 4 months by the Parenting Stress Index and the Edinburgh Post Natal Depression Scale. At 4 months the quality of the home environment was assessed, utilizing the Home Observation for Measurement of the Environment Inventory, as were child and family health parameters and satisfaction with the community child health service.
                At 4 month follow-up, 160 families (80 intervention, 80 control) were available for assessment. The intervention improved family functioning at 4 months. All aspects of the home environment, including the quality of maternal-infant attachment and mothers' relationship with their child, were significantly enhanced. In particular, significant and positive differences were found in parenting with the intervention group feeling less restrictions imposed by the parenting role, greater sense of competence in parenting, greater acceptability of the child, and the child being more likely to provide positive reinforcement to the parent. Early differences in maternal mood were not maintained at 4 months. Various child health parameters were enhanced including immunization status, fewer parent-reported injuries and bruising, and researcher confirmed lack of smoking in the house or around the infant. The families were consistently more satisfied with their community health service.
                This form of early home based intervention targeted to vulnerable families promotes an environment conducive for infant mental and general health and hence long-term psychological and physical well-being, and is highly valued by the families who receive it. To evaluate the effects of psychosocial support during labour, delivery and the immediate postpartum period provided by a female companion (doula).
                The effects of the intervention were assessed by means of a randomised clinical trial. Social support by a doula was provided to women in the intervention group, while women in the control arm received routine care.
                A large social security hospital in Mexico City.
                Seven hundred and twenty-four women with a single fetus, no previous vaginal delivery, < 6 cm of cervical dilatation, and no indications for an elective caesarean section were randomly assigned to be accompanied by a doula, or to receive routine care.
                Breastfeeding practices, duration of labour, medical interventions, mother's emotional conditions, and newborn's health.
                Blinded interviewers obtained data from the clinical records, during encounters with women in the immediate postpartum period, and at their homes 40 days after birth. Relative risks and confidence intervals were estimated for all relevant outcomes.
                The frequency of exclusive breastfeeding one month after birth was significantly higher in the intervention group (RR 1.64; I-C: 1.01-2.64), as were the behaviours that promote breastfeeding. However, the programme did not achieve a significant effect on full breastfeeding. More women in the intervention group perceived a high degree of control over the delivery experience, and the duration of labour was shorter than in the control group (4.56 hours vs 5.58 hours; RR 1.07 CI (95%) = 1.52 to -0.51). There were no effects either on medical interventions, mothers' anxiety, self-esteem, perception of pain and satisfaction, or in newborns' conditions.
                Psychosocial support by doulas had a positive effect on breastfeeding and duration of labour. It had a more limited impact on medical interventions, perhaps because of the strict routine in hospital procedures, the cultural background of the women, the short duration of the intervention, and the profile of the doulas. It is important to include psychosocial support as a component of breastfeeding promotion strategies. Interventions to reduce health inequalities for young children and their mothers are important: involving peers is recommended, but evidence of value for this approach is limited. The authors aimed to examine the effect of an innovative tailored peer-mentoring programme, based on perceived needs, for first-time mothers in socio-economically deprived communities.
                Randomised controlled trial; parallel qualitative study with purposive samples using semistructured interviews.
                Socio-economically disadvantaged areas, Belfast.
                Primigravidae, aged 16-30 years, without significant co-morbidity.
                Peer-mentoring by a lay-worker fortnightly during pregnancy and monthly for the following year, tailored to participants' wishes (home visits/telephone contacts), additional to usual care.
                Infant psychomotor and mental development (Bayley Scales of Infant Development (BSID-II)) at 1 year, assessed by an observer blinded to group allocation. Mothers' health at 1 year postnatal (SF-36).
                Of 534 women invited, 343(64%) participated; 85%, with their children, completed outcome assessments (140 of 172 intervention; 152 of 171 controls). Intervention and control groups did not differ in BSID-II psychomotor (mean difference 1.64, 95% CI -0.94 to 4.21) or mental (-0.81, -2.78 to 1.16) scores, nor SF-36 physical functioning (-5.4, -11.6 to 0.7) or mental health (-1.8, -6.1 to 2.6). Women valued advice given in context of personal experience of child-rearing. Mentors gained health-related knowledge, personal skills and new employment opportunities.
                Despite possible longer-term social advantage, this peer-mentoring programme showed no benefit for infant development or maternal health at 1 year. Further rigorous evaluation of important outcomes of complex interventions promoting health for children in socially disadvantaged communities is warranted. TRIAL REGISTRATION NO: ISRCTN 55055030. Vaccination of health care workers (HCWs) is recommended as a strategy for preventing influenza in elderly patients in long-term care. However, there have been no controlled studies to show whether this approach is effective. During the winter of 1994-1995, 1059 patients in 12 geriatric medical long-term-care sites, randomized for vaccination of HCWs, were studied. In hospitals where HCWs were offered vaccination, 653 (61%) of 1078 were vaccinated. Vaccination of HCWs was associated with reductions in total patient mortality from 17% to 10% (odds ratio [OR], 0.56; 95% confidence interval [CI], 0.40-0.80) and in influenza-like illness (OR, 0.57; 95% CI, 0.34-0.94). Vaccination of patients was not associated with significant effects on mortality (OR, 1.15; 95% CI, 0.81-1.64). Results of this study support recommendations for vaccination against influenza of HCWs in long-term geriatric care. Vaccination of frail elderly long-term-care patients may not give clinically worthwhile benefits. One hundred children 6 to 24 month old, normal or undernourished according to weight for height index, received during three months--autumn to winter--a dietary supplement of live Lactobacillus acidophilus and Lactobacillus Casei, 10(7)-10(8)/ml in fermented milk (LB) or an equivalent amount of fluid milk (L) as control. Children's follow-up was performed as outpatients in the Hospital Posadas (Great Buenos Aires). Episodes of respiratory tract infections were recorded and classified according to severity as: Pneumonia (N); Bronchitis (B), Recurrent Obstructive Bronchitis (BOR) and upper respiratory tract infections (CVAS). 58% of children fitted the study protocol, 22 in the LB and 36 in the L group; 21 were undernourished and 37 presented normal weight/height. No deaths were recorded. Total episodes were 103: 34 in LB and 69 in L, that means a frequency of 1.55 and 1.92 episodes/children respectively. In LB a maximum of 3 episodes/children was recorded, meanwhile the number reached 7 in L (p = 0.0373). Severity was higher in L than LB: 0.06 vs. 0 for N; 0.69 vs. 0.45 for B + BOR and 1.17 vs. 1.09 for CVAS. In the control group frequency of severe pathologies was about twice in undernourished than in normal: 0.08 vs. 0.04 for N; 1.08 vs. 0.50 for B + BOR; no difference was found for CVAS. Live lactobacillus supplement suppressed pneumonia and decreased bronchitis in undernourished as well as in normal. In this study undernutrition not only increased the chance of suffering severe acute respiratory tract infections but also impaired the effectiveness of the supplement to decrease severity. The effect is explained on the basis of the immunocompetence depression linked to an inadequate nutritional status. To investigate the impact of a long-term nurse home visiting programme, embedded within a universal child health system, on the health, development and well-being of the child, mother and family.
                Randomised controlled trial.
                208 (111 intervention, 97 comparison) eligible at-risk mothers living in a socioeconomically disadvantaged area in Sydney, booking into the local public hospital for confinement.
                A sustained and structured nurse home visiting antenatal and postnatal parenting education and support programme.
                Usual universal care.
                The quality of the home environment for child development (12-24 months), parent-child interaction and child mental, psychomotor and behavioural development at 18 months.
                Mothers receiving the intervention were more emotionally and verbally responsive (HOME observation) during the first 2 years of their child's life than comparison group mothers (mean difference 0.5; 95% CI 0.1 to 0.9). Duration of breastfeeding was longer for intervention mothers than comparison mothers (mean difference 7.9 weeks; 95% CI 2.9 to 12.9). There was no significant difference in parent-child interaction between the intervention and comparison groups. There were no significant overall group differences in child mental, psychomotor or behavioural development. Mothers assessed antenatally as having psychosocial distress benefitted from the intervention across a number of areas.
                This sustained nurse home visiting programme showed trends to enhanced outcomes in many, but not all, areas. Specifically, it resulted in clinically enhanced outcomes in breastfeeding duration and, for some subgroups of mothers, women's experience of motherhood and children's mental development.
                ACTRN12608000473369. Despite growing evidence of the benefits of prolonged breastfeeding for mother and infant health, the rate of breastfeeding at infant age of 6 months remains below the Healthy People 2010 goal. The greatest decrease in the breastfeeding rate occurs during the first 4 postpartum weeks. Mothers who discontinue breastfeeding early are more likely to report lack of confidence in their ability to breastfeed, problems with the infant latching or suckling, and lack of individualized encouragement from their clinicians in the early postdischarge period. Observational studies suggest that primary care physicians can increase breastfeeding rates through specific advice and practices during routine preventive visits. However, robust scientific evidence based on randomized, controlled trials is currently lacking.
                The purpose of this study was to determine whether attending an early, routine, preventive, outpatient visit delivered in a primary care physician's office would improve breastfeeding outcomes.
                The study was a prospective, randomized, parallel-group, open trial.
                Participants were recruited at a level 3 maternity facility, with an average of 2000 births per year, in France.
                A total of 231 mothers who had delivered a healthy singleton infant (gestational age: > or =37 completed weeks) and were breastfeeding on the day of discharge were recruited and randomized (116 were assigned to the intervention group and 115 to the control group) between October 1, 2001, and May 31, 2002; 226 mother-infant pairs (112 in the intervention group and 114 in the control group) contributed data on outcomes.
                Support for breastfeeding in the control group included the usual verbal encouragement provided by the maternity ward staff members, a general health assessment and an evaluation for evidence of successful breastfeeding behavior by the pediatrician working in the obstetrics department on the day of discharge, provision of the telephone number of a peer support group, mandatory routine, preventive, outpatient visits at 1, 2, 3, 4, 5, and 6 months of infant age, and 10 weeks of paid maternity leave (extended to 18 weeks after the birth of the third child). In addition to the usual predischarge and postdischarge support, the mothers in the intervention group were invited to attend an individual, routine, preventive, outpatient visit in the office of 1 of the 17 participating primary care physicians (pediatricians or family physicians) within 2 weeks after the birth. The participating physicians received a 5-hour training program on breastfeeding, delivered in 2 parts in 1 month, before the beginning of the study.
                The primary outcome was the prevalence of exclusive breastfeeding reported at 4 weeks (defined as giving maternal milk as the only food source, with no other foods or liquids, other than vitamins or medications, being given). The secondary outcomes included any breastfeeding reported at 4 weeks, breastfeeding duration, breastfeeding difficulties, and satisfaction with breastfeeding experiences. Classification into breastfeeding categories reported at 4 weeks was based on 24-hour dietary recall.
                Ninety-two mothers (79.3%) assigned to the intervention group and 8 mothers (7.0%) assigned to the control group reported that they had attended the routine, preventive, outpatient visit in the office of 1 of the 17 primary care physicians participating in the study. Mothers in the intervention group were more likely to report exclusive breastfeeding at 4 weeks (83.9% vs 71.9%; hazard ratio: 1.17; 95% confidence interval [CI]: 1.01-1.34) and longer breastfeeding duration (median: 18 weeks vs 13 weeks; hazard ratio: 1.40; 95% CI: 1.03-1.92). They were less likely to report any breastfeeding difficulties (55.3% vs 72.8%; hazard ratio: 0.76; 95% CI: 0.62-0.93). There was no significant difference between the 2 groups with respect to the rate of any breastfeeding at 4 weeks (89.3% vs 81.6%; hazard ratio: 1.09; 95% CI: 0.98-1.22) and the rate of mothers fairly or very satisfied with their breastfeeding experiences (91.1% vs 87.7%; hazard ratio: 1.04; 95% CI: 0.95-1.14).
                Although we cannot exclude the possibility that findings might differ in other health care systems, this study provides preliminary evidence of the efficacy of breastfeeding support through an early, routine, preventive visit in the offices of trained primary care physicians. Our findings also suggest that a short training program for practicing physicians might contribute to improving breastfeeding outcomes. Multifaceted interventions aiming to support breastfeeding should involve primary care physicians. We evaluated the efficacy of probiotics in reducing the incidence and severity of necrotizing enterocolitis (NEC) in very low birth weight (VLBW) infants.
                A prospective, masked, randomized control trial was conducted to evaluate the beneficial effects of probiotics in reducing the incidence and severity of NEC among VLBW (<1500 g) infants. VLBW infants who started to fed enterally and survived beyond the seventh day after birth were eligible for the trial. They were randomized into 2 groups after parental informed consents were obtained. The infants in the study group were fed with Infloran (Lactobacillus acidophilus and Bifidobacterium infantis) with breast milk twice daily until discharged. Infants in the control group were fed with breast milk alone. The clinicians caring for the infants were blinded to the group assignment. The primary outcome was death or NEC (>or= stage 2).
                Three hundred sixty-seven infants were enrolled: 180 in the study group and 187 in the control group. The demographic and clinical variables were similar in both groups. The incidence of death or NEC (>or= stage 2) was significantly lower in the study group (9 of 180 vs 24 of 187). The incidence of NEC (>or= stage 2) was also significantly lower in the study when compared with the control group (2 of 180 vs 10 of 187). There were 6 cases of severe NEC (Bell stage 3) in the control group and none in the study group. None of the positive blood culture grew Lactobacillus or Bifidobacterium species.
                Infloran as probiotics fed enterally with breast milk reduces the incidence and severity of NEC in VLBW infants. Routine antenatal Rh immunoprophylaxis would substantially increase the use of anti-D Ig in the U.K. As availability of anti-D Ig is one factor influencing a decision to introduce routine antenatal prophylaxis, a trial was undertaken to test the efficacy of a lower dose of anti-D Ig than that used in earlier studies. RhD-negative primigravidae were randomized as controls or recipients of two doses of 250iu of anti-D Ig given at 28 and 34 weeks gestation. Blood samples were tested at delivery and at 6 months postpartum for the presence of immune anti-D, and again later if results were equivocal. Nine (1.5%) out of 595 control patients had immune anti-D at follow-up at 6 months and later; 4 (0.78%) of 513 treated women were immunized. It was concluded that, while two doses of 250iu of anti-D Ig may reduce alloimmunization, they are not as effective as two doses of 500iu in a previous trial. Recent observations have shown that treatment with high-dose intravenous gammaglobulin (IVIgG) given to the mother may improve fetal outcome in cases of severe Rh D alloimmunization. Unfortunately, the costs of this new method of treatment are too high for routine use. Therefore, we decided to apply this treatment to the fetus and to investigate whether the effect of IVIgG might be attributable to blockade of the fetal mononuclear phagocyte system. We have performed a randomized study in which 20 fetuses with severe Rh D-haemolytic disease (HDN) were treated with intrauterine intravascular red cell transfusions (IUT). In 10 of these 20 cases transfusions were followed by administration to the fetus of low-dose IVIgG (85.7 +/- 11.6 mg/kg by ultrasound-estimated fetal weight because of fetal vascular volume considerations). We compared the number of IUTs, postnatal exchange transfusions, haematocrit (Ht) and haemoglobulin (Hb) values before and after transfusion (s) needed by the newborns of the two groups. No significant differences in the transfusion requirements of the fetuses and in the clinical outcome could be demonstrated. However, the 95% confidence interval for the difference in the improvement of cord blood Ht was too wide for any conclusions. The 95% confidence interval for the difference in the improvement of Hb levels suggests that any clinically relevant advantage of IVIgG on Hb is unlikely. The objective was to investigate whether the addition of thyrotropin-releasing hormone to antepartum betamethasone further reduces the incidence of respiratory disease in preterm infants.
                A randomized, placebo-controlled, double-blind trial of antepartum thyrotropin-releasing hormone (400 micrograms given intravenously four times) and betamethasone (5 mg given intramuscularly four times) was conducted in 378 mothers likely to be delivered between 24 and 32.6 weeks' gestation. Statistical analysis was by relative risk, chi 2, t tests, and multiple logistic regression analysis.
                Four hundred five live-born infants were delivered. In infants without lethal abnormalities delivered between 24 hours and 10 days from entry (n = 175) the incidence of respiratory distress syndrome was reduced from 52% to 31% (relative risk 0.61, 95% confidence interval 0.41 to 0.89) and that of severe respiratory distress syndrome from 42% to 20% (relative risk 0.48, 95% confidence interval 0.29 to 0.78) in the placebo and thyrotropin-releasing hormone groups, respectively. The number of deaths fell from 14 to one (relative risk 0.08, 95% confidence interval 0.01 to 0.63). The incidence of chronic lung disease was not significantly different, but that of an adverse outcome (chronic lung disease or death by 36 weeks' gestation) fell from 29% in the placebo group to 16% with thyrotropin-releasing hormone (relative risk 0.55, 95% confidence interval 0.31 to 0.99).
                The addition of thyrotropin-releasing hormone to antepartum glucocorticoid treatment reduces the incidence of respiratory distress syndrome and improves survival in preterm infants. Exclusive breastfeeding increases survival and optimizes growth of low-birthweight (LBW) infants. If supported, mothers can overcome the unique difficulties associated with breastfeeding from birth to 6 mo. We tested the efficacy of postnatal peer counselling among first-time mothers that aimed to increase exclusive breastfeeding of term LBW infants.
                In a Manila hospital, 204 mothers were randomized into three groups. Two intervention groups receiving home-based counselling visits, one by counsellors trained in breastfeeding counselling (n=68), the other by counsellors trained in general childcare (n=67), were compared with a control group of mothers (n=69) who did not receive counselling.
                Eighty-eight per cent of the participating pairs completed the trial. At 6 mo, 44% of the breastfeeding counselled mothers, 7% childcare-counselled mothers and none of the mothers in the control group were exclusively breastfeeding. More mothers in the breastfeeding counselled group than in the other groups were still breastfeeding at 6 mo. Twenty-four infants who were exclusively breastfed for 6 mo did not have any diarrhoea. All groups had improved mean weight-for-age Z-scores at 6 mo.
                This study has provided fundamental evidence of successful intervention to achieve 6 mo of exclusive breastfeeding among term LBW infants. By improving health outcomes, enhanced breastfeeding offers a distinct possibility of disrupting the intergenerational cycle of undernourished women giving birth to LBW infants. Respiratory tract infections (RTIs) are the most common infections in humans, and it is difficult to effectively treat patients with increased susceptibility to these ailments. LW 50020 (Luivac; Paspat oral), an oral immunomodulator consisting of the antigens of seven bacteria commonly involved in RTIs, has been developed for the induction of specific and nonspecific immune responses of the mucosa-associated lymphoid tissue. In this placebo-controlled study, the efficacy and safety of the tablet formulation of LW 50020 were evaluated in children and adults with recurrent RTIs. Tablets were taken once daily during two periods of 4 weeks each, interrupted by a treatment-free interval of 4 weeks. The main endpoint of the study, a clinical severity score that evaluated treatment benefits, was significantly lower in the second study period in patients treated with the bacterial lysate compared to patients given placebo. A comparison of the infection rates in the first and second study periods of patients treated with LW 50020 revealed a placebo-corrected reduction of 39% in children and a placebo-corrected reduction of 44% in adolescents and adults. The placebo-corrected duration of infections was shortened by 47% in children and by 55% in older patients. No serious drug-related side effects occurred. This study demonstrated that the oral bacterial immunomodulator LW 50020 is efficacious in treating patients with recurrent RTIs. To show if surfactant applied in different social-sanitary realities as prophylaxis of respiratory distress syndrome (RDS) is equally useful and able to reduce mortality and incidence of 3-4 radiological grade RDS.
                Two neonatal intensive care units (NICU) in Italy, one NICU in Bulgaria and one NICU in Romania were involved in a randomized controlled clinical trial of prophylaxis vs rescue treatment of RDS. Babies with gestational age 26-30 wks were randomized before birth to prophylaxis in the delivery-room with 200 mg/kg of porcine surfactant (prophylaxis) or to routine assistance (control). Subsequently the babies developing RDS requiring mechanical ventilation and fraction of inspired oxygen (FiO2) > or = 0.4 to maintain PaO2 about 50 mmHg were allowed to be treated rescue with 200 mg/kg of the same surfactant. To reach end-points of reducing mortality by 40% and incidence of radiological grade 3-4 RDS a total number of 174 patients were required.
                Due to logistic, practical and social-political problems the study was interrupted after enrollment of 93 babies (61 in Italy and 32 in Bulgaria). The Romanian centre did not start the study because it was impossible in the scheduled times to equip it for mechanical ventilation of the newborn infants. Analysis done on an intention to treat basis did not show significant reductions of mortality and 3-4 radiological grade RDS, even if there was a trend towards a reduction in the babies given prophylaxis. A significantly lower number of babies given prophylaxis required a subsequent rescue treatment compared to controls (p < 0.001). There was no difference in other complications such as intraventricular haemorrhage, air-leak syndromes and infections between prophylaxis and control infants. As regards pulmonary gas exchange, the PaO2/FiO2 ratio was significantly improved in the babies given prophylaxis for the first 12 hours of life vs the controls.
                Even if the study was terminated before term, the analysis of the data shows that prophylaxis with surfactant is equally effective in different social-clinical conditions to improve pulmonary gas-exchange, especially in the first critical hours of life of premature babies. Newborn infants of Chinese HBeAg-carrier mothers in Hong Kong were randomly assigned to one of four study groups. Group I was treated with 3 micrograms heat-inactivated hepatitis B (HB) vaccine at birth and at 1, 2, and 6 months thereafter, in conjunction with seven monthly HBIg injections; group II was treated according to the same vaccine schedule but received only one HBIg injection at birth; group III received only the vaccine, at months 0, 1, 2, and 6; and group IV received placebos for both vaccine and HBIg. The first set of injections was given within 1 h after birth. Comparisons were made in the 140 children who were at least six months old at the close of the trial (495 days). In all three treatment groups development of the persistent carrier state was significantly (p less than or equal to 0.0001) less frequent than in controls (2.9%, 6.8%, and 21.0% versus 73.2%). Although vaccination alone was significantly less protective than vaccination plus multiple HBIg injections (p = 0.03), the degree of protection was still remarkable. 12 months after the first set of injections 96-100% of the infants in the three treatment groups were anti-HBs positive; the geometric mean titres of anti-HBs in the three groups did not differ significantly. This indicates that even high doses of HBIg do not interfere with the anti-HBs response to the vaccine. Probable intra-uterine HB infections were observed in 3 infants. No serious side-effects were observed from the interventions, even in the babies with intra-uterine infections who had received HBIg and HB-vaccine at birth. To prevent development of the persistent HBsAg carrier state, and thereby the consequent chronic liver disease and/or primary carcinoma of the liver, HB vaccine and HBIg should be administered as soon as possible after birth to all newborn infants at risk of perinatal hepatitis B infection. This randomized clinical trial compared frequencies of exclusive breastfeeding and lactation-related problems during the first 30 days among 74 mothers who received a 30-minute counseling session on breastfeeding technique in the maternity ward, and 137 controls. The frequency of exclusive breastfeeding among mothers who had received intervention was similar to controls by 7 days (79.7% vs 82.5%, respectively) and 30 days (60.8% vs 53.3%). There was no difference between groups in the frequency of sore nipples at 7 and 30 days, in breast engorgement and mastitis, and in the quality of breastfeeding technique at 30 days. Therefore, a single intervention at maternity was not sufficient to improve breastfeeding technique, increase exclusive breastfeeding rates, and reduce the incidence of breastfeeding problems during the first month. To measure the effects of supportive companionship on labour and various aspects of adaptation to parenthood, and thus by inference the adverse effects of a clinically orientated labour environment on these processes.
                Randomized controlled trial.
                A community hospital familiar to most of the participants, with a conventional, clinically-orientated labour ward.
                Nulliparous women in uncomplicated labour.
                Supportive companionship from volunteers from the community with no medical nor nursing experience, concentrating on comfort, reassurance and praise.
                Duration of labour, use of analgesia, perceptions of labour and breastfeeding success.
                Companionship had no measurable effect on the progress of labour. Diastolic blood pressure and use of analgesia were modestly but significantly reduced. The support group were more likely to report that they felt that they had coped well during labour (60 vs 24%, P less than 0.00001). Their mean labour pain scores (26.0 vs 44.2, P less than 0.00001) and state anxiety scores (28.2 vs 37.8, P less than 0.00001) were lower than those of the control group. Compared with the control group (n = 75), at 6 weeks women in the support group (n = 74) were more likely to be breastfeeding exclusively (51 vs 29%, P less than 0.01); and to be feeding at flexible intervals (81 vs 47%, P less than 0.0001).
                Labour in a clinical environment may undermine women's feelings of competence, perceptions of labour, confidence in adapting to parenthood and initiation of successful breastfeeding. These effects may be reduced by the provision of additional companionship during labour aimed to promote self-esteem. The effect of breastfeeding on reestablishment of ovulation and fertility and on birth spacing are now well known. A study was conducted on lactational amenorrhoea (LAM) at 180 days in Hoima District, Uganda in order to understand whether and how LAM could be applied in fertility control and birth spacing. Since the introduction of supplementary food by Ugandan women does not replace or substitute for breastfeeding, a study was designed to determine if LAM was effective irrespective of supplementation of infant's diet. One hundred and fifty four mother/child pairs were entered into the study and 134 women completed the sixth month of the study. At the end of the period, eighty four women (62.7%) were amenorrhoeic of whom only 33 (39.3%) were exclusively breastfeeding and no woman had dropped out of the study because of pregnancy or the use of other family planning methods other than LAM. The study confirmed that LAM could be applicable in Uganda to the majority of the breastfeeding women (62.7%). It is expected that if health workers increase the intensity of breastfeeding support as well as the women's knowledge and motivation to use LAM for family planning, this would contribute to children's health as well as to birth spacing that is one of the major factors related to infant deaths. According to data from this study, the return of menses is irrespective of whether supplements have been introduced and their frequency. We implemented community-based direct observation of treatment, short course (DOTS), including a randomized controlled trial of direct observation either by community health workers (CHWs) or family members, under operational conditions in a region of Swaziland. There was a high death rate of 15%, due to the high HIV rates in the region. There was no significant difference in the cure and completion rate between direct observation of treatment by CHWs and family members [2% difference (95% CI -3% to 7%), exact P = 0.52]. A before-and-after comparison of outcomes demonstrated that the cure and treatment completion rate improved from a baseline of 27-67% following implementation of community-based DOTS. We conclude that community-based tuberculosis DOTS can improve successful outcomes of treatment. However, direct observation can be undertaken effectively using either daily family or CHW supervision. The choice of treatment supporter should be based on access, patient preference and availability of CHW resource. A multicenter study of the Lactational Amenorrhea Method (LAM) was carried out to test the acceptability and efficacy of the method. Additionally, the data are used to test new constructs for improvement of method criteria. A protocol was designed at the Institute for Reproductive Health (IRH), Department of Obstetrics and Gynecology, Georgetown University Medical Center, a World Health Organization (WHO) Collaborating Center, and was reviewed and modified in collaboration with the co-sponsors, the World Health Organization and the South to South Cooperation for Reproductive Health, and the principal investigators from each site. Data were gathered prospectively on LAM acceptors at 11 sites. Data were entered and cleaned on-site and further cleaned and analyzed at IRH, using country-level and pooled data to produce descriptive statistics and life tables. The 98+% efficacy of LAM is confirmed in a wide variety of settings. In addition, the results yield insight on the possibility of continued use beyond 6 months. LAM is found to be highly effective as an introductory postpartum method when offered in a variety of cultures, health care settings, socio-economic strata, and industrial and developing country locales. In addition, LAM acceptance complements breastfeeding behaviors without ongoing breastfeeding support services. The parameters studied yield high efficacy and method continuation. Therefore, the basic tenets of the 1995 Bellagio consensus on LAM is reconfirmed and it is recommended that LAM be reconfirmed and it is recommended that LAM be incorporated into hospital, maternity, family planning, maternal and child health, and other primary health care settings. A prospective intervention study was undertaken in Santiago, Chile, to assess the impact of a breastfeeding promotion program and the acceptance and use of the lactational amenorrhea method for natural child spacing. The intervention study significantly increased the duration of exclusive breastfeeding and amenorrhea. In addition, the use of the lactational amenorrhea method proved highly efficacious, with an unplanned pregnancy rate of less than 0.5% by 6-month cumulative life table. Total family planning coverage at 6 months was increased in the intervention group. The THORN trial was a multicenter, randomized, double-blind, placebo-controlled clinical trial to test the hypothesis that administration of triiodothyronine (T(3)) and hydrocortisone would decrease mortality and respiratory morbidity in preterm infants of less than 30 wk gestation. Two hundred fifty-three infants were randomized to receive either 6 micro g.kg(-1).d(-1) of T(3) with 1 mg.kg(-1).d(-1) of hydrocortisone or 5% dextrose (placebo) as a continuous i.v. infusion for 7 d. The dose was halved on d 5. Our first primary outcome was death or ventilator dependence at 1 wk, and the second was death or oxygen dependence at 2 wk. The overall mortality rate for both groups was 11.4%. Relative risk of death or ventilator dependence at 1 wk, treated versus placebo, was 0.87, p = 0.2, and death or oxygen dependence at 2 wk, 1.00, p = 0.9. We examined the relationship between free T(3) (FT(3)) and free thyroxine (FT(4)) levels in the first 7 d and the primary outcome death or ventilator dependence at 1 wk in all 253 babies. We found significant positive correlations of p = 0.05 for FT(3) and p = 0.002 for FT(4). Thus the higher the FT(3) and FT(4) levels, the better the outcome. No beneficial effects of T(3) and hydrocortisone were shown. In this study, although FT(3) levels were doubled by the treatment infusion, FT(4) levels were significantly suppressed. The lack of any beneficial effect of T(3) in our study may be explained by suppression of FT(4) in the treatment group. To compare the hospital course and clinical outcome of preterm infants with respiratory distress syndrome treated with surfactant and managed with high-frequency oscillatory ventilation (HFOV) or conventional mechanical ventilation (CV) as their primary mode of ventilator support.
                A prospective randomized clinical trial.
                Three community-based level III neonatal intensive care units.
                A total of 125 neonates who were 35 weeks or less estimated gestation requiring intubation and assisted ventilation for respiratory distress syndrome with arterial to alveolar oxygen ratio less than .50.
                Patients were randomized to continue CV (61 patients) or be changed to HFOV (64 patients) after exogenous surfactant administration (100 mg/kg). HFOV was used in a strategy to promote lung recruitment and maintain lung volume. Protocol respiratory care guidelines were followed; otherwise routine care was provided by each neonatal intensive care unit.
                No differences were noted in demographic features between the two study groups. The study population birth weight was 1.51 +/- .47 kg (mean +/- SD), gestational age was 30.9 +/- 2.5 weeks, and study entry age was 2 to 3 hours. Patients randomized to HFOV demonstrated the following significant findings compared with CV-treated patients: vasopressor support was less intensive; surfactant redosing was not as frequent; oxygenation improved more rapidly and remained higher during the first 7 days; fewer infants required prolonged supplemental oxygen or ventilator support; treatment failure was reduced; more patients survived without chronic lung disease at 30 days; need for continuous supplemental oxygen at discharge was less; frequency of necrotizing enterocolitis illness was lower; there were fewer abnormal hearing tests; and hospital costs were decreased. No differences were seen between the two study groups in the frequency or severity of patent ductus arteriosus, air leak, retinopathy of prematurity, or intraventricular hemorrhage. Length of hospital stay and survival to discharge were similar for HFOV- and CV-treated infants.
                When used early with a lung recruitment strategy, HFOV after surfactant replacement resulted in clinical outcomes consistent with a reduction in both acute and chronic lung injury. Benefit was evident for preterm infants both less than or equal to 1 kg and more than 1 kg. In addition, early HFOV treatment may have had a more global effect on patient health throughout the hospitalization, resulting in reduced morbidity and decreased health care cost. Increased acute lower respiratory infection incidence, severity, and mortality are associated with malnutrition, and reduced immunological competence may be a mechanism for this association. Because zinc deficiency results in impaired immunocompetence and zinc supplementation improves immune status, we hypothesized that zinc deficiency is associated with increased incidence and severity of acute lower respiratory infection.
                We evaluated the effect of daily supplementation with 10 mg of elemental zinc on the incidence and prevalence of acute lower respiratory infection in a double-blind, randomized, controlled trial in 609 children (zinc, n = 298; control, n = 311) 6 to 35 months of age. Supplementation and morbidity surveillance were done for 6 months.
                After 120 days of supplementation, the percentage of children with plasma zinc concentrations <60 microg/dL decreased from 35.6% to 11.6% in the zinc group, whereas in the control group it increased from 36.8% to 43.6%. Zinc-supplemented children had 0.19 acute lower respiratory infection episodes/child/year compared with 0.35 episodes/child/year in the control children. After correction for correlation of data using generalized estimating equation regression methods, there was a reduction of 45% (95% confidence interval, 10% to 67%) in the incidence of acute lower respiratory infections in zinc-supplemented children.
                A dietary zinc supplement resulted in a significant reduction in respiratory morbidity in preschool children. These findings suggest that interventions to improve zinc intake will improve the health and survival of children in developing countries. Breastfeeding Friendly Primary Care Initiative comprises educational activities focused on primary care units. The To evaluate the effectiveness of a strategy on breastfeeding promotion to the Family Health Program team.
                A controlled intervention study was performed with 20 family health care teams randomly selected into intervention and control group in Montes Claros, Southeastern Brazil, in 2006. The teams randomly selected into intervention and control group, and the intervention group took part in a 24-hour training program on breastfeeding promotion for health providers, modeled on the Baby-Friendly Hospital Initiative. It was emphasized health provider's support for breastfeeding and management of major lactation problems. The control group received routine breastfeeding training. Mothers of all children under two cared by the teams were interviewed at home before (n=1,423) and 12 months after the intervention (n=1,491) and answered questions about breastfeeding practices. Survival curves of breastfeeding were plotted and compared for both time points studied using the log rank test.
                There was a significant increase in exclusive breastfeeding after the educational activities for the Family Health Program teams. Survival curves of exclusive breastfeeding at the fi rst time point studied showed no statistical significance difference between the groups by log rank test (p=0.502). After the intervention, survival curves of exclusive breastfeeding were significantly different by the log rank test (p=0.001).
                The training of Family Health Program teams as proposed by the Baby-Friendly Hospital Initiative proved to be an effective, low-cost strategy for raising awareness among health providers, providing consistent information, and assuring the required support to mothers with breastfeeding issues. Purified acellular pertussis vaccine (12.5 micrograms of lymphocytosis promoting factor [LPF] and 12.5 micrograms of filamentous hemagglutinin [FHA]) was compared with conventional pertussis vaccine in a randomized double-blind study involving 40 children aged 4-6 y, 40 children aged 18-24 mo, and 50 infants. Increases in antibody were significantly greater among recipients of acellular vaccine than among recipients of conventional vaccine for antibodies to LPF in all age groups and for antibodies to FHA in infants and children aged 4-6 y; the increase in FHA antibody was also greater with acellular vaccine among children aged 18-24 mo but not significantly so. Compared with conventional vaccine, acellular vaccine was significantly associated with reduced frequency of leg pain and fretfulness at all ages and less frequent fever and anorexia at some ages. The reduced reaction rates and comparable or enhanced immunogenicity of the acellular vaccine make it an attractive candidate for larger field trials, particularly among infants. Stresses imposed by parenthood can provoke or intensify relationship problems between parents. These problems, which are often associated with postnatal depression, can have serious consequences for family well-being but are often not revealed to primary health care personnel.
                To evaluate a means of extending the primary health care team's ability to identify and respond to relationship problems of mothers and their partners in the postnatal period.
                Cluster randomised controlled trial.
                Specially trained health visitors in nine 'intervention' clinics--each matched with a 'control' clinic' in an outer London borough.
                Health visitors in intervention clinics invited mothers attending for the six-to-eight-week developmental check to complete a screening scale for relationship problems, and offered help (supportive listening, advice, or referral) if needed. When visiting the clinic for the 12-week immunizations, mothers from all clinics were asked to complete a follow-up self-report questionnaire. After the completion of the trial, 25 women who had attended the intervention clinics and had been offered support with a relationship problem were interviewed to elicit their views on the acceptability and value of the intervention. All 25 of the health visitors engaged in the intervention were asked to complete a questionnaire on their experience.
                Screening led to striking differences between intervention and control clinics in the percentage of women identified at the six-to-eight-week check as potentially in need of help with a relationship problem (21% versus 5%, P = 0.007) and in the percentage actually offered help (18% versus 3%, P = 0.014). About one-half of the mothers so identified were also identified as having postnatal depression. At the 12-week visit for immunizations, the intervention group was twice as likely (P = 0.006) as the control group to report having discussed relationship problems with the health visitor and 75% more likely (P = 0.046) to report having received help with a problem.
                The intervention offers a useful way of extending the primary health care team's ability to respond to problems that often have serious consequences for family well-being. Social support theory and observational risk factor studies suggest that increased antenatal psychosocial support could prevent post-natal depression. We used empirical knowledge of risk and protective factors for post-natal depression not employed previously in order to develop and evaluate an antenatal preventive intervention.
                We conducted a pragmatic randomized controlled trial in antenatal clinics. We screened 1300 primiparous women and 400 screened positive, 69 screen-positive women were untraceable or not eligible. Of 292 women who completed baseline assessment, 209 consented to randomization, of these 190 provided outcome data 3 months post-natally. 'Preparing for Parenthood', a structured antenatal risk factor reducing intervention designed to increase social support and problem-solving skills, was compared with routine antenatal care only. We compared the percentage depressed at 3 months after childbirth using the self-completion General Health Questionnaire Depression scale and Edinburgh Post-natal Depression Scale (EPDS), and the Schedules for Clinical Assessment in Neuropsychiatry a systematic clinical interview.
                Assignment to the intervention group did not significantly impact on post-natal depression (odds ratio for GHQ-Depression 1.22 (95% CI 0.63-2.39), P = 0.55) or on risk factors for depression. Forty-five per cent of the intervention group women attended sufficient sessions to be likely to benefit from intervention if effective. Attenders benefited no more than non-attenders.
                Prevention services targeting post-natal depression should not implement antenatal support programmes on these lines until further research has demonstrated the feasibility and effectiveness of such methods. The development of novel, low cost interventions effective in reducing risk factors should be completed before further trial evaluation. Scaling-up of effective preventive interventions in child and maternal health is constrained in many developing countries by lack of demand. In Latin America, some governments have been trying to increase demand for health interventions by making direct payments to poor households contingent on them keeping up-to-date with preventive health services. We undertook a public health programme effectiveness trial in Honduras to assess this approach, contrasting it with a direct transfer of resources to local health teams.
                70 municipalities were selected because they had the country's highest prevalence of malnutrition. They were allocated at random to four groups: money to households; resources to local health teams combined with a community-based nutrition intervention; both packages; and neither. Evaluation surveys of about 5600 households were undertaken at baseline and roughly 2 years later. Pregnant women and mothers of children younger than 3 years old were asked about use of health services (primary outcome) and coverage of interventions such as immunisation and growth monitoring (secondary outcome). Reports were supplemented with data from children's health cards and government service utilisation data. Analysis was by mixed effects regression, accounting for the municipality-level randomisation.
                The household-level intervention had a large impact (15-20 percentage points; p<0.01) on the reported coverage of antenatal care and well-child check-ups. Childhood immunisation series could thus be started more opportunely, and the coverage of growth monitoring was markedly increased (15-21 percentage points; p<0.01. Measles and tetanus toxoid immunisation were not affected. The transfer of resources to local health teams could not be implemented properly because of legal complications.
                Conditional payments to households increase the use and coverage of preventive health care interventions. A diphtheria and tetanus toxoid two-component acellular pertussis vaccine (DTaP), consisting of 25 micrograms glutaraldehyde-detoxified pertussis toxin (PT) and 25 micrograms native filamentous hemagglutinin (FHA), was compared with diphtheria and tetanus toxoid whole-cell pertussis vaccine (DTwP) in a randomized, double-blind manner in 286 Senegalese infants inoculated at two, four, and six months of age. In infants receiving DTaP a significantly lower rate of local reactions, crying and fever was observed than in infants receiving DTwP. One month after the third dose, the geometric mean titres for FHA antibodies were higher in the DTaP group, whereas increases in PT antibody titres were higher in the DTwP group. More than 90% of the infants had a fourfold or more increase in antibodies to both PT and FHA with either vaccine. Diphtheria, tetanus, and polio antibody responses were also measured and found to be comparable between the two groups. The results of this pilot study support the implementation of a field trial to compare the protective efficacy of these vaccines against pertussis in the same setting. Over a period of 6 months the effect of home visits on compliance with directly observed therapy, short course (DOTS), was studied on 480 new smear-positive tuberculosis patients who had delayed collecting their drugs on one occasion. Patients registered at 15 tuberculosis treatment centres in Baghdad, Iraq, were randomized to an intervention group (receiving home visits from trained personnel) or a control group. Home visits were highly effective in improving the return to treatment of patients who were late for treatment (231/240, 96.3%). The intervention group showed a higher treatment success rate (94.2% versus 76.7%), lower default rate (0.8% versus 10.0%) and higher smear conversion rate after the end of treatment (92.9% versus 75.0%) than controls. Home visiting by trained personnel significantly improves patient compliance with DOTS. Day care is increasingly being used for complications of pregnancy, but there is little published evidence on its efficacy. We assessed the clinical, psychosocial, and economic effects of day care for three pregnancy complications in a randomised trial of day care versus standard care on an antenatal ward.
                395 women were randomly assigned day (263) or ward (132) care in a ratio of two to one, stratified for major diagnostic categories (non-proteinuric hypertension, proteinuric hypertension, and preterm premature rupture of membranes). The research hypothesis was that for these disorders, as an alternative to admission, antenatal day care will reduce specified interventions and investigations, result in no differences in clinical outcome, lead to greater satisfaction and psychological wellbeing, and be more cost-effective. Data were collected through case-note review, self-report questionnaires (response rates 81.0% or higher) and via the hospital's financial system. Analysis was by intention to treat.
                All participants were included in the analyses. There were no differences between the groups in antenatal tests or investigations or intrapartum interventions. The total duration of antenatal care episodes was shorter in the day-care group than in the ward group (median 17 [IQR 5-9] vs 57 [35-123] h; p=0.001). Overall stay was also significantly shorter in the day-care group (mean 7.22 [SE 0.31] vs 8.53 [0.44]; p=0.014). The median number of care episodes was three (range one to 14) in the day-care group and two (one to nine) in the ward group (p=0.01). There were no statistically or clinically significant differences in maternal or perinatal outcomes. The day-care group reported greater satisfaction, with no evidence of unintended psychosocial sequelae. There was no significant difference in either average cost per patient or average cost per day of care.
                Since clinical outcomes and costs are similar, adoption by maternity services of a policy providing specified women with the choice between admission and day-unit care seems appropriate. A total of 522 children between 18 months and 14 years and 191 adults between 18 and 60 years were vaccinated with TBE-vaccine according to an abbreviated schedule (0, 7, 21). The aim of the study was to investigate whether reducing the amount of antigen in the vaccination for children would preserve an adequate immune response and decrease the rate of side-effects. Efficacy was determined on the extent to which children, vaccinated with the low doses (0.4 microgram or 0.75 microgram), reacted by developing antibodies in the same way as adults treated with the approved dose of 1.5 micrograms (equivalence of titres). The titres obtained in the children with the two lower doses were equivalent to those in the adults obtained with the standard dose. Titres decreased in the children with increasing age. Children older than 12 years in the approved dosage group had the same median titres as adults. The frequency of side-effects in the two lower dose groups, especially raised temperature, was markedly reduced. Whereas 30.1% of the children vaccinated with the approved dose had raised temperature higher than 38 degrees C only 18.8% and 18.4%, respectively, of the children vaccinated with the lower doses developed such temperatures. This improved tolerance in terms of raised temperature was also reflected in the other general reactions such as tiredness, joint pain or headache.
LHWs provide promising benefits in promoting immunisation uptake and breastfeeding, improving TB treatment outcomes, and reducing child morbidity and mortality when compared to usual care. For other health issues, evidence is insufficient to draw conclusions about the effects of LHWs.