Two-Year Follow-up of a Randomized Controlled Nutrition Intervention Trial in Very Low-Birth-Weight Infants

Background: Very low-birth-weight (VLBW) infants are at risk for neurodevelopment impairment. This study assessed the effect of early aggressive parenteral nutrition (PN) on long-term outcome in VLBW infants. Materials and Methods: Directly after birth, VLBW infants (birth weight <1500 g, n = 142) were randomized to 5 different PN regimes. Controls (n = 46) received glucose and standard-dose amino acids (AAs; 2.4 g/[kg.d]) from birth onward and pure soybean oil fat emulsion (SOY) on the second day of life. Two intervention groups received glucose, standard-dose AAs, and lipids from birth onward: SOY (n = 24) or mixed fat emulsion (MIX, n = 25). The 2 other intervention groups received glucose, high-dose AAs (3.6 g/[kg.d]), and lipids from birth onward: SOY (n = 24) or MIX (n = 23). The primary outcome of this follow-up study was the composite outcome of death or major disability at 2 years corrected age. Secondary outcomes were death, major disabilities, neurodevelopmental scores, and anthropometry. Results: Follow-up rate was 92% (n = 134). Thirty-five (26%) infants had died or had a major disability, with no differences between intervention groups and controls. Increased odds for death were observed in the standard-dose AA-MIX group (odds ratio, 5.4; 95% confidence interval [CI], 1.1-27.0). Neurodevelopmental scores and incidence of major disabilities did not differ between groups. Growth in the high-dose AA-MIX group was enhanced compared with growth in controls at 2 years corrected age (+0.51 [0.01-1.02] weight SDS). Conclusion: This randomized controlled hypothesis-generating study demonstrated no beneficial effect of early high-dose AA administration and mixed fat emulsions on survival and neurodevelopmental outcome in VLBW infants, although growth was enhanced.