Effect of timing and method of enteral tube feeding for dysphagic stroke patients (FOOD): a multicentre randomised controlled trial. The favorable effect of early parenteral feeding on survival in head-injured patients. Tube feeding in the demented elderly with severe disabilities. A randomized, controlled, a single-blind trial of nutritional supplementation after acute stroke. Maternal dietary counseling in the first year of life is associated with a higher healthy eating index in childhood. Early versus delayed feeding with an immune-enhancing diet in patients with severe head injuries. Early enteral feeding does not affect the incidence of necrotizing enterocolitis. The risk factors and impact on survival of feeding tube placement in nursing home residents with severe cognitive impairment. Dietary counselling and food fortification in stable COPD: a randomised trial. A prospective, randomized trial of early enteral feeding after resection of upper gastrointestinal malignancy. Early minimal feedings promote growth in critically ill premature infants.
Undernutrition is common in patients admitted with stroke. We aimed to establish whether the timing and route of enteral tube feeding after stroke affected patients' outcomes at 6 months.
                The FOOD trials consist of three pragmatic multicentre randomised controlled trials, two of which included dysphagic stroke patients. In one trial, patients enrolled within 7 days of admission were randomly allocated to early enteral tube feeding or no tube feeding for more than 7 days (early versus avoid). In the other, patients were allocated percutaneous endoscopic gastrostomy (PEG) or nasogastric feeding. The primary outcome was death or poor outcome at 6 months. Analysis was by intention to treat.
                Between Nov 1, 1996, and July 31, 2003, 859 patients were enrolled by 83 hospitals in 15 countries into the early versus avoid trial. Early tube feeding was associated with an absolute reduction in risk of death of 5.8% (95% CI -0.8 to 12.5, p=0.09) and a reduction in death or poor outcome of 1.2% (-4.2 to 6.6, p=0.7). In the PEG versus nasogastric tube trial, 321 patients were enrolled by 47 hospitals in 11 countries. PEG feeding was associated with an absolute increase in risk of death of 1.0% (-10.0 to 11.9, p=0.9) and an increased risk of death or poor outcome of 7.8% (0.0 to 15.5, p=0.05).
                Early tube feeding might reduce case fatality, but at the expense of increasing the proportion surviving with poor outcome. Our data do not support a policy of early initiation of PEG feeding in dysphagic stroke patients. This prospective randomized controlled clinical trial compares the effects of early parenteral nutrition and traditional delayed enteral nutrition upon the outcome of head-injured patients. Thirty-eight head-injured patients were randomly assigned to receive total parenteral nutrition (TPN) or standard enteral nutrition (SEN). Clinical and nutritional data were collected on all patients until death or for 18 days of hospitalization. Survival and functional recovery were monitored in survivors for 1 year. Of the 38 patients, 18 were randomized to the SEN group and 20 to the TPN group. Demographically, the two groups of patients were similar on admission. There was no significant difference in the severity of head injury between the two groups as measured by the Glasgow Coma Scale (p = 0.52). The outcome for the two groups was quite different, with eight of the 18 SEN patients dying within 18 days of injury, whereas no patient in the TPN group died within this period (p less than 0.0001). The basis for the improved survival in the TPN patients appears to be improved nutrition. The TPN patients had a more positive nitrogen balance (p less than 0.06), and a higher serum albumin level and total lymphocyte count. More adequate nutritional status may have improved the patients' immunocompetence, resulting in decreased susceptibility to sepsis. The data from this study strongly support the favorable effect of early TPN on survival from head injury. Despite the ongoing debate on tube feeding of severely demented patients, the current approach in western countries is to avoid feeding by tube.
                To assess the clinical course and outcome of demented elderly patients with severe disabilities, by feeding mode.
                The study was conducted in a skilled nursing department of a major psychogeriatric hospital in Israel. Eighty-eight patients aged 79 +/- 9 years were followed for 17 months: 62 were fed by nasogastric tube and 26 were orally fed. The groups were compared for background characteristics, underlying medical condition, functional impairment, clinical and nutritional outcomes, and survival.
                Tube feeding had no beneficial effect on clinical and nutritional outcomes or on healing preexisting pressure ulcers, compared with oral feeding. Very few patients on tube feeding showed signs of discomfort, partly because of low cognitive function. Survival was significantly higher in the tube-fed patients (P < 0.001), which could be partly explain by the different case mix (i.e., the underlying diseases)
                Tube feeding seems to have no nutritional advantage in severely demented elderly patients. Median survival was longer in tube-fed individuals who had no acute co-morbidity. However, since tube feeding does not add to patient pain and discomfort, it should not be contraindicated when it complies with the values and wishes of patients and their families. Although stroke patients who do not have difficulty swallowing may be at risk of undernutrition and worsening nutritional status during hospitalization, optimum methods for nutrition intervention in stroke patients have not been established.
                To examine the feasibility of enteral sip feeding as an effective nutrition intervention after acute stroke.
                Forty-two acute ischemic stroke inpatients with impaired nutritional status who did not have difficulty swallowing within 1 week after the stroke were entered into a single-blind, randomized, controlled, prospective study of enteral sip feeding. Twenty-one patients were randomized to receive daily oral food supplements for 4 weeks in addition to the hospital food, and 21 patients received only the hospital food for the same period. Main outcome measures were energy and protein intakes during the intervention period, change in nutritional status, disability, infective complications, length of stay, and mortality during hospitalization and at 3 months.
                Two patients, one from each group, were lost to follow-up immediately after randomization. Twenty patients received oral nutritional supplementation. The energy intake was significantly greater in the supplemented group: 1807 +/- 318 vs 1084 +/- 343 kcal/d (mean +/- SD; p < .0001) (estimated treatment effect, 723 kcal/d; 95% confidence interval [CI], 498 to 947), as was protein intake: 65.1 +/- 13.8 vs 44.1 +/- 12.8 g/d (p < .001) (estimated treatment effect, 21.0 g/d; 95% CI, 11.7 to 30.3). There also were significant differences between the two groups in the changes in serum albumin and serum iron concentrations between randomization and at follow-up. There was a trend to lower mortality at 3 months in the supplemented group with two deaths (10%) compared with seven deaths (35%) in the control group (p = .127, relative risk, 0.29; 95% CI, 0.07 to 1.21).
                This study suggests that enteral sip feeding is effective in improving nutritional intake and status in stroke patients who do not have swallowing difficulties. There also may be some beneficial effects on clinical outcome, but larger studies are required to confirm this observation and define more precisely the magnitude of any favorable effects. Food preferences are established in early childhood and track later in life. Therefore, it is important to promote healthy feeding practices as early as possible. A randomized field trial was conducted with 500 mother-child pairs from a low-income area of São Leopoldo, State of Rio Grande do Sul, Brazil, to evaluate the impact of a nutritional intervention in the first year of life on the dietary quality of 3- to 4-y-old children. Mother-child pairs were randomized either to intervention and control groups and dietary counseling was provided for mothers in the intervention group during 10 home visits in the course of the first year of life. These visits were carried out by fieldworkers who counseled the mothers about the Ten Steps for Healthy Feeding from Birth to Two Years of Age, based on the WHO guidelines. Dietary intake was assessed at 3-4 y of age for 345 children using two 24-h food recalls. Overall diet quality was determined by the Healthy Eating Index. The prevalence of poor diet in the intervention group was lower compared with the control group [relative risk (RR) = 0.30; 95% CI = 0.13-0.71). The number of children who achieved the 75th percentile for the vegetable and fruit component score was higher in the intervention than in control group (RR = 1.95; 95% CI = 1.31-2.89 and RR = 1.49; 95% CI = 1.07-2.07, respectively). Such data provide evidence that dietary counseling for mothers during the first year of life improves the overall dietary quality of children in a low-income population. Although early enteral feeding clearly reduces septic morbidity after blunt and penetrating trauma, data for head-injured patients are conflicting. This study examines the effects of early vs delayed enteral feedings on outcome in patients with severe closed-head injuries with a Glasgow Coma Scale (GCS) score greater than 3 and less than 11.
                Thirty patients were prospectively randomized to receive an immune-enhancing diet (Impact with fiber) early (initiated < 72 hours after trauma) delivered via an endoscopically placed nasoenteric tube (Stay-Put) or late (administered after gastric ileus resolved). This formula was continued for 14 days or until the patient tolerated oral feeding. Goal rate of nutrition was 21 nonprotein cal/kg/d and 0.3 g N/kg/d.
                Two patients in the early group were excluded due to inability to place the tube, and one patient in the late group died before 72 hours. Five of the remaining 27 died, 1 in the early group and 4 in the late group. There were no significant differences between the groups in length of stay, intensive care unit (ICU) days, significant infection, or GCS score. However, major infection correlated inversely with admission GCS score (R = -0.6, p < .003). Time to reach a GCS score of 14 was significantly longer in patients with significant infections compared with those without (p < .02).
                No difference in length of stay or infectious complications is shown in patients with severe closed-head injury when they are given early vs delayed feeding using an immune-enhancing formula. Severity of the head injury is closely associated with significant infection. To begin to determine the optimal time for initiating enteral feedings, 34 sick, very low birth weight infants were prospectively selected from all neonates of less than 1,500 g (N = 116) and randomly divided into two groups. Infants were fed either on day 1 (early) or 7 (late) of life, according to a feeding protocol which included parenteral nutrition and a scheduled progression from sterile water to 2.5% dextrose, half-strength, and finally full-strength formula over seven days. The incidence of necrotizing enterocolitis and subsequent hospital course were compared. Initiating enteral feedings on day 1 did not significantly increase the incidence of necrotizing enterocolitis, produce a clustering of cases, or induce an earlier onset of necrotizing enterocolitis. The overall incidence of necrotizing enterocolitis in sick, very low birth weight neonates was 29% (5/17) and 35% (6/17) in the early and late groups, respectively, compared with 4.2% (2/47) in minimally sick, very low birth weight neonates. No significant differences between groups were seen in obstetrical complications, birth weight, gestational age, Apgar scores, presence of patent ductus arteriosus or intraventricular hemorrhage, use of umbilical catheterization, and respiratory or oxygen requirements. Infants fed enterally from day 1 did show a significantly higher energy and protein intake during the second week of life. These data show that providing dilute, early enteral calories does not adversely affect the incidence of necrotizing enterocolitis. The provision of artificial enteral nutrition to an aged person with severe cognitive impairment is a complex dilemma in the long-term care setting.
                To determine the risk factors and impact on survival of feeding tubes in nursing home residents with advanced cognitive impairment.
                We conducted a cohort study with 24-month follow-up using Minimum Data Set resident assessments on 1386 nursing home residents older than 65 years with recent progression to severe cognitive impairment in the state of Washington. Residents within this population who underwent feeding tube placement were identified. Clinical characteristics and survival for a period of 24 months were compared for residents who were and were not tube fed.
                Among the residents with recent progression to severe cognitive impairment, 9.7% underwent placement of a feeding tube. Factors independently associated with feeding tube placement included age younger than 87 years (odds ratio [OR], 1.85; 95% confidence interval [CI], 1.25-2.78), aspiration (OR, 5.46; 95% CI, 2.66-11.20), swallowing problems (OR, 3.00; 95% CI, 1.81-4.97), pressure ulcer (OR, 1.64; 95% CI, 1.23-2.95), stroke (OR, 2.12; 95% CI, 1.17-2.62), less baseline functional impairment (OR, 2.07; 95% CI, 1.27-3.36), no do-not-resuscitate order (OR, 3.03; 95% CI, 1.92-4.85), and no dementia (OR, 2.17; 95% CI, 1.43-3.22). Survival did not differ between groups of residents with and without feeding tubes even after adjusting for independent risk factors for feeding tube placement.
                There are specific risk factors associated with feeding tube placement in nursing home residents with severe cognitive impairment. However, there is no survival benefit compared with similar residents who are not tube fed. These prognostic data are important for health care providers, families, and patients making decisions regarding enteral nutritional support in long-term care. Malnutrition in chronic obstructive pulmonary disease (COPD) is associated with a poor prognosis, yet evidence to support the role of dietary counselling and food fortification is lacking. A study was undertaken to assess the impact of dietary counselling and food fortification on outcome in outpatients with COPD who are at risk of malnutrition.
                A randomised controlled unblinded trial was performed in 59 outpatients with COPD (6 months intervention and 6 months follow-up). The intervention group received dietary counselling and advice on food fortification and the controls received a dietary advice leaflet. Outcome measures were nutritional status, respiratory and skeletal muscle strength, respiratory function, perceived dyspnoea, activities of daily living (ADL) and quality of life.
                The intervention group consumed more energy (difference 194 kcal/day; p = 0.02) and protein (difference 11.8 g/day; p<0.001) than controls. The intervention group gained weight during the intervention period and maintained weight during follow-up; the controls lost weight throughout the study. Significant differences were observed between the groups in St George's Respiratory Questionnaire total score (difference 10.1; p = 0.02), Short Form-36 health change score (difference 19.2; p = 0.029) and Medical Research Council dyspnoea score (difference 1.0; p = 0.03); the difference in ADL score approached statistical significance (difference 1.5; p = 0.06). No differences were observed between groups in respiratory function or skeletal and respiratory muscle strength. Improvements in some variables persisted for 6 months beyond the intervention period.
                Dietary counselling and food fortification resulted in weight gain and improvements in outcome in nutritionally at-risk outpatients with COPD, both during and beyond the intervention period. The purpose of the study was to determine whether early postoperative enteral feeding with an immune-enhancing formula (IEF) decreases morbidity, mortality, and length of hospital stay in patients with upper gastrointestinal (GI) cancer.
                Early enteral feeding with an IEF has been associated with improved outcome in trauma and critical care patients. Evaluable data documenting reduced complications after major upper GI surgery for malignancy with early enteral feeding are limited.
                Between March 1994 and August 1996, 195 patients with a preoperative diagnosis of esophageal (n = 23), gastric (n = 75), peripancreatic (n = 86), or bile duct (n = 11) cancer underwent resection and were randomized to IEF via jejunostomy tube or control (CNTL). Tube feedings were supplemented with arginine, RNA, and omega-3 fatty acids, begun on postoperative 1, and advanced to a goal of 25 kcal/kg per day. The CNTL involved intravenous crystalloid solutions. Statistical analysis was by t test, chi square, or logistic regression.
                Patient demographics, nutritional status, and operative factors were similar between the groups. Caloric intake was 61% and 22% of goal for the IEF and CNTL groups, respectively. The IEF group received significantly more protein, carbohydrate, lipids and immune-enhancing nutrients than did the CNTL group. There were no significant differences in the number of minor, major, or infectious wound complications between the groups. There was one bowel necrosis associated with IEF requiring reoperation. Hospital mortality was 2.5% and median length of hospital stay was 11 days, which was not different between the groups.
                Early enteral feeding with an IEF was not beneficial and should not be used in a routine fashion after surgery for upper GI malignancies. Critically ill premature infants requiring mechanical ventilation and an umbilical artery catheter usually do not receive enteral feedings during the acute phase of their illness. We studied the safety and benefit of early minimal enteral feedings during this time in a prospective, controlled, and randomized study. Twenty-nine infants were randomly assigned to receive only standard intravenous fluid and nutrition (nothing per OS, NPO group; n = 13), or in addition to receive small-volume hypocaloric continuous feedings (1 ml/kg/h), beginning at 24 h of age (early-feeding group; n = 16). Standard enteral feedings were begun in both groups at the resolution of the acute phase of the illness and advanced by protocol. The two groups were of comparable birth weight, gestational age, and Apgar scores. There were no significant differences in the episodes of feeding intolerance. Two infants in the NPO group developed clinical signs of necrotizing enterocolitis. Serum diamine oxidase and somatomedin C were measured weekly until 30-60 days of age and were not different between the two groups. The early-feeding group required fewer days to reach 120 ml/kg/day enteral intake (early-feeding group 10 +/- 3 days, NPO group 13 +/- 4 days; p < 0.05). On day 30 of life the early-feeding group was 223 +/- 125 g above birth weight, while the NPO group was 95 +/- 161 g above birth weight (p < 0.05). The average intake (kcal/kg/day) from day 6 to day 30 was not different between the two groups. We conclude that early minimal feedings in critically ill very-low-birth-weight infants requiring mechanical ventilation are well tolerated and result in reduced time to reach 120 ml/kg/day of enteral feeding and in a greater weight gain by day 30 of life.
This review suggests that early feeding may be associated with a trend towards better outcomes in terms of survival and disability. Further trials are required. These trials should report not only nutritional outcomes but also the effect on death and disability.