Complex milk lipids (CML) provide critical nutrients for neurodevelopment in infants. Beneficial effects of CML on brain functions have been extensively shown in rodents. The rapidly developing neonatal brain is vulnerable to nutrient insufficiency but also possesses a high degree of plasticity. This study was designed to test the hypothesis that infant formula enriched with CML improves neurodevelopmental outcomes at 12 months of age. Healthy, full-term infants (n = 418) at age ≤ 21 days were randomized to breastfeeding, standard infant formula, standard formula enriched with CML. The primary objective was the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) assessment of neurodevelopmental outcome at age 12 months. …show more content…
During the first 42 days, infants in the breastfeeding group (n = 206) gained 2.74 g/d more weight compared with the formula-feeding group (n = 212). At age 4 months, the prevalence of high hemoglobin count (hemoglobin > 128 g/L) was significantly higher in the formula-feeding group compared with the breastfeeding group. At age 6 months, mean length and head circumference increases in the formula-feeding group were 8.19 and 6.26 mm larger than those in the breastfeeding group. The differences were trivial in adverse event and morbidity rates between breastfeeding and formula-feeding groups. The most important determinants of breastfeeding in the studied population are maternal concurrent conditions, maternal age and maternal education level. CML-enriched formula was non-inferior to standard formula in growth and tolerance during the 6-month feeding. The infants in the formula-feeding group might have had slightly faster growth rate during the first 6