Early Amino Acid Intake in ELBW Infants: School-Aged Outcomes From a Randomized Controlled Trial.

Abstract

To investigate if providing additional parenteral amino acids to extremely low birthweight (ELBW) infants improves neurocognitive function, lean mass, and muscle strength at early school age, without adverse effects on blood pressure and general health. Multicenter, 2-arm parallel, double-blinded randomized trial of an additional 1 g/d of parenteral amino acids for 5 days after birth or placebo (1:1 ratio), with follow-up at 6 to 7 years old' corrected age. The primary outcome was survival free of neurocognitive impairment, defined as a standard score more than 1 SD below the age-corrected mean in 1 or more National Institutes of Health Toolbox cognitive and motor tests. Fifteen secondary outcomes included measures of motion perception, numeracy, body size and composition, blood pressure, and emotional-behavioral and psychosocial health. Of 309 eligible children, 280 (153 [55%] girls) were assessed at school age. The proportion surviving without neurocognitive impairment was similar between the amino acid and placebo groups (21% vs 23%; adjusted risk difference [aRD], -5.0; 95% CI, -12.8 to 2.7; P = .21). Children in the amino acid group had lower muscle strength than placebo group (relative handgrip strength z-score: mean, -0.73 [SD, 1.01] vs mean, -0.33 [SD, 1.17]; adjusted mean difference, -0.39; 95% CI, -0.65 to -0.13) and may have had increased risk of low psychosocial functioning (26% vs 18%; aRD, 10.7; 95% CI, -1.3 to 22.6). Other secondary outcomes were similar between groups. In ELBW infants, providing an additional 1 g/d of parenteral amino acids for 5 days after birth has little to no effect on survival without neurocognitive impairment at school age and may have adverse effects on strength and psychosocial functioning.