Introduction of intravenous lipid administration on the first day of life in the very low birth weight neonate. Randomised trial of effect of delayed intravenous lipid administration on chronic lung disease in preterm neonates. Effect of early initiation of intravenous lipid administration on the incidence and severity of chronic lung disease in premature infants. Impact of pharmacy counseling on compliance and effectiveness of combination lipid-lowering therapy in patients undergoing coronary artery revascularization: a randomized, controlled trial. A randomized trial of 72- versus 24-hour intravenous tubing set changes in newborns receiving lipid therapy.
To investigate lipid tolerance in sick, ventilator-dependent, very low birth weight infants from the first day of life and the effects of early introduction of intravenously administered lipid (IVL) on glucose homeostasis.
                Twenty-nine infants in the neonatal intensive care unit with birth weight less than 1500 gm received isocaloric, isonitrogenous parenteral feedings from day 1 with either IVL, 1 gm/kg from day 1 to 3 gm/kg from day 4 (group I; n = 16), or IVL added only from day 8 (group II; n = 13). Possible adverse clinical effects were monitored. Blood metabolites, nonesterified fatty acids, serum triglycerides, and insulin levels were determined daily. Arterial blood gases were measured and changes in partial pressures of oxygen and of carbon dioxide in arterial blood were compared between the two groups.
                Early lipid infusion did not appear to have deleterious effects on blood gas tensions or to increase respiratory morbidity. The incidence of other adverse clinical effects that may be associated with IVL was not increased by earlier introduction of lipid. Serum lipid values were comparable to those of preterm infants receiving IVL at a later postnatal age. Blood glucose concentrations were higher in group II (mean, 7.50 (SEM 0.43) mmol/L) than in group I (mean, 6.01 (SEM 0.28) mmol/L; p less than 0.05). There was no evidence of increased gluconeogenesis in infants in group I and no correlation between blood glucose concentrations and serum nonesterified fatty acid concentrations.
                When given infusion rates not exceeding 0.15 gm/kg/hr, sick, very low birth weight infants can tolerate IVL with stepwise dose increases from the first day of life without an increased incidence of possible adverse effects. A recent sevenfold increase in the annual incidence of chronic neonatal lung disease (CNLD) on an intensive care unit was attributed to the early administration of intravenous lipid (IVL) in ventilated preterm neonates. When logistic regression was used to eliminate other confounding variables, early delivery of IVL was independently associated with an eight-fold increase in the likelihood of CNLD. Consequently, we designed a prospective study to detect a halving of the incidence of CNLD by delaying IVL administration from 5 days (as is routine practice) to 14 days. Sixty-four parenterally fed preterm neonates weighing < 1,500 g at birth were randomised to receive IVL either on day 5 or day 14. Analysis was by intention to treat, since several infants in the latter group required no parenteral nutrition by day 14. Our results showed that the relative risk (95% confidence interval) of CNLD at 28 postnatal days was 1.15 (0.81-1.62); at 36 weeks postconception, it was 1.08 (0.59-1.99). A study population of > 2,000 would be required to determine whether these relative risks were significantly different from 1. To investigate whether intravenous administration of lipid nutrition (Intralipid) within 12 hours of birth to ventilator-dependent premature infants would decrease the incidence or severity, or both, of chronic lung disease.
                We randomly assigned 133 infants to Intralipid or control groups, using two weight strata: 42 Intralipid versus 37 control subjects in the 600 to 800 gm stratum, and 28 Intralipid versus 26 control subjects in the 801 to 1000 gm stratum. The Intralipid group received 20% Intralipid at < 12 hours after birth, starting at a dose of 0.5 gm/kg and increasing to a maximum of 1.5 gm/kg, maintained through day 7. Control infants received no lipid until after day 7. Neither group received enteral feedings until after day 7.
                No significant differences in mortality rates were present in the total population (23/70 = 32.9% vs 16/63 = 25.4%; p = 0.35, Intralipid vs control); however, the mortality rate increased significantly in 600 to 800 gm infants receiving Intralipid versus the control infants (20/41 = 47.5% vs 9/37 = 24.3%; p = 0.032). No significant differences were found in the number of infants in whom chronic lung disease developed (requiring oxygen for > or = 28 days), proportion requiring oxygen for > or = 60 days, number of survivors without chronic lung disease, or total oxygen and ventilation requirements. However, 600 to 800 gm infants receiving Intralipid had significantly more pulmonary hemorrhage, and greater numbers of infants receiving Intralipid in both weight categories required supplemental oxygen at day 7. The incidence of other complications of prematurity, time required to regain birth weight, and duration of hospital stay did not differ between groups.
                Intralipid administration initiated at < 12 hours after birth failed to protect very low birth weight premature infants from chronic lung disease. Some of the results raise questions about possible deleterious effects of Intralipid when administered early in the first week of life. This randomized, controlled trial evaluated the impact of personalized follow-up on compliance rates in high-risk patients receiving combination lipid-lowering therapy over 2 years. A random sample of 30 patients 7-30 days after cardiac surgery had baseline fasting low-density lipoprotein levels higher than 130 mg/dl. All patients received lovastatin 20 mg/day and colestipol 5 g twice/day. Weekly telephone contact was made with each patient for 12 weeks. Short- and long-term compliance was assessed by pill and packet counts and refill records. Compliance and lipid profile results were significantly better in the intervention group (p<0.05) up to 2 years after the start of therapy than in the control group for all parameters except high-density lipoprotein. However, this effect was not apparent during the first 12 weeks of therapy. Short-term telephone follow-up favorably affected compliance and lipid profile results up to 2 years after start of therapy. To compare the microbial contamination rate of infusate in the intravenous tubing of newborns receiving lipid therapy, replacing the intravenous delivery system at 72-hour versus 24-hour intervals.
                Infants requiring intravenous lipid therapy were randomly assigned to have intravenous sets changed on a 72- or a 24-hour schedule, in a 3:1 ratio, in order to compare the infusate contamination rates in an equivalent number of tubing sets.
                A 35-bed, teaching, referral, neonatal intensive-care unit (NICU).
                All neonates admitted to the NICU for whom intravenous lipid was ordered.
                Patients were randomized in pharmacy, on receipt of the order for intravenous lipid therapy, to either 72- or 24-hour administration set changes, and followed until 1 week after discontinuation of lipids or discharge from the NICU. Microbial contamination of the infusate was assessed in both groups at the time of administration set changes. Contamination rates were analyzed separately for the lipid and amino acid-glucose tubing sets. Patient charts were reviewed for clinical and epidemiological data, including birth weight, gestational age, gender, age at start of lipid therapy, duration of parenteral nutrition, and type of intravenous access.
                During the study period, 1,101 and 1,112 sets were sampled in the 72- and 24-hour groups, respectively. Microbial contamination rates were higher in the 72-hour group than the 24-hour group for lipid infusions (39/1,101 [3.54%] vs 15/1,112 [1.35%]; P=.001) and for amino acid infusions (12/1,093 [1.10%] vs 4/1,103 [0.36%]; P=.076). Logistic regression analysis controlling for birth weight, gestational age, and type of venous access showed that only the tubing change interval was significantly associated with lipid set contaminations (odds ratio, 2.69; P=.0013). The rate of blood cultures ordered was higher in the 72- versus the 24-hour group (6.11 vs 4.99 per 100 patient days of total parenteral nutrition; P=.017), and a higher proportion of infants randomized to the 72-hour group died (8% vs 4%; P=.05), although the excess deaths could not clearly be attributed to bacteremia.
                Microbial contamination of infusion sets is significantly more frequent with 72- than with 24-hour set changes in neonates receiving lipid solutions. This may be associated with an increased mortality rate.
No statistically significant effects of 'early introduction' of lipids on short term nutritional or other clinical outcomes, either benefits or adverse effects, were demonstrated in the studies reviewed. Based on the currently available evidence, 'early' initiation of lipids (≤ 5 days after birth) can not be recommended for short term growth or to prevent morbidity and mortality in preterm infants.