Early amino acids in extremely preterm infants and neurological disorders at 2 years
It is unknown whether higher parenteral amino acid intake improves outcomes in extremely low birth weight infants.
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In this multicenter, parallel-group, double-blind, randomized, placebo-controlled trial, we assigned infants with a birth weight of less than 1000 g in 8 neonatal intensive care units to receive amino acids at a dose of 1 g per day (group intervention) or placebo in addition to usual nutrition for the first 5 days after birth. The primary outcome was neurodeficiency-free survival, assessed using the Bayley Scale for Infant and Toddler Development and neurological examination at 2 years, corrected for gestational age at birth. The secondary endpoints were the components of the primary endpoint as well as the presence or absence of neonatal disorders, growth rate and nutritional intake.
We recruited 434 infants (217 per group) in this trial. Neurological disease-free survival was observed in 97 of 203 children (47.8%) in the intervention group and in 102 of 205 (49.8%) in the placebo group (adjusted risk ratio, 0.95; confidence interval at 95%). [CI], 0.79 to 1.14; p=0.56). Death before the age of 2 years occurred in 39 of 217 children (18.0%) in the intervention group and 42 of 217 (19.4%) in the placebo group (adjusted relative risk, 0.93; at 95%, 0.63 to 1.36); neurological disability occurred in 67 of 164 children (40.9%) in the intervention group and 61 of 163 (37.4%) in the placebo group (adjusted relative risk, 1.16; 95% CI, 0. 90 to 1.50). Neurological impairment was moderate to severe in 27 children (16.5%) in the intervention group and 14 (8.6%) in the placebo group (adjusted relative risk, 1.95; 95% CI, 1. 09 to 3.48). More children in the intervention group than in the placebo group had a patent ductus arteriosus (adjusted relative risk, 1.65; 95% CI, 1.11 to 2.46). In a post hoc analysis, refeeding syndrome occurred in 42 of 172 children in the intervention group and 26 of 166 in the placebo group (adjusted relative risk, 1.64; 95% CI, 1.09 to 2.47 ). Eight serious adverse events occurred.
In extremely low birth weight infants, extra parenteral amino acids at a dose of 1 g daily for 5 days after birth did not increase the number of survivors without neurological damage at 2 years. (Funded by the New Zealand Health Research Council and others; Australian New Zealand ProVIDe Clinical Trials Registry Number, ACTRN12612001084875.)