Neurodevelopmental Effects of Donor Human Milk vs. Preterm Formula in ELBW infants

The MILK Trial was a multicenter randomized trial of fortified donor human milk versus preterm formula for extremely low gestational age newborns receiving no or minimal maternal milk to compare neurodevelopmental outcomes at age 22-26 months of age. The trial enrolled 483 infants aged ? 29 0/7 weeks of age who were less than or equal to 72 hours of life at the time of admission to the neonatal intensive care unit and survived for at least 12 hours. The Bayley Scales of Infant and Toddler Development (BSID) served as the primary outcome measure, and no significant difference in neurodevelopmental outcomes were noted between the two study arms. Secondary outcomes studied included BSID language and motor scores, in-hospital growth, occurrence of necrotizing enterocolitis, and death.