IMPORTANCE For many very low-birth-weight (VLBW) infants, there is insufficient mother's milk, and a supplement of pasteurized donor human milk or preterm formula is required. Awareness of the benefits of mother's milk has led to an increase in use of donor milk, despite limited data evaluating its efficacy.OBJECTIVE To determine if nutrient-enriched donor milk compared with formula, as a supplement to mother's milk, reduces neonatal morbidity, supports growth, and improves neurodevelopment in VLBW infants. DESIGN, SETTING, AND PARTICIPANTSIn this pragmatic, double-blind, randomized trial, VLBW infants were recruited from 4 neonatal units in Ontario, Canada, within 96 hours of birth between October 2010 and December 2012. Follow-up was completed in July 2015.INTERVENTIONS Infants were fed either donor milk or formula for 90 days or to discharge when mother's milk was unavailable. MAIN OUTCOMES AND MEASURESThe primary outcome was the cognitive composite score on the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) at 18 months' corrected age (standardized mean, 100 [SD,15]; minimal clinically important difference, 5 points). Secondary outcomes included Bayley-III language and motor composite scores, growth, and a dichotomous mortality and morbidity index. RESULTSOf 840 eligible infants, 363 (43.2%) were randomized (181 to donor milk and 182 to preterm formula); of survivors, 299 (92%) had neurodevelopment assessed. Mean birth weight and gestational age of infants was 996 (SD, 272) g and 27.7 (2.6) weeks, respectively, and 195 (53.7%) were male. No statistically significant differences in mean Bayley-III cognitive composite score (adjusted scores, 92.9 in donor milk group vs 94.5 in formula group; fully adjusted mean difference, −2.0 [95% CI, −5.8 to 1.8]), language composite score (adjusted scores, 87.3 in donor milk group vs 90.3 in formula group; fully adjusted mean difference, −3.1 [95% CI, −7.5 to 1.3]), or motor composite score (adjusted scores, 91.8 in donor milk group vs 94.0 in formula group; fully adjusted mean difference, −3.7 [95% CI, −7.4 to 0.09]) were observed between groups. There was no statistically significant difference in infants positive for the mortality and morbidity index (43% in donor milk group, 40% in formula group) or changes in growth z scores.CONCLUSIONS AND RELEVANCE Among VLBW infants, use of supplemental donor milk compared with formula did not improve neurodevelopment at 18 months' corrected age. If donor milk is used in settings with high provision of mother's milk, this outcome should not be considered a treatment goal.

Despite the introduction of more aggressive early feeding guidelines and improved energy and nutrient intakes compared with literature values, many VLBW infants remain below recommended nutrition goals in the first week.

Background: Hospitalized VLBW infants fed human milk are reported to have lower growth rates compared to those fed nutrient‐enriched formulas. Aggressive parenteral nutrition guidelines for VLBW infants have been adopted in many neonatal intensive care units (NICUs) in response to data confirming short‐term safety of this approach and potential long‐term neurocognitive benefits. However, actual intakes during the first week of life have not been extensively evaluated since adoption of these guidelines. Objective: To describe the parenteral and enteral energy and macronutrient intakes in human milk‐fed VLBW infants from NICUs with aggressive nutrition guidelines. Design: Daily parenteral and enteral intakes were prospectively collected for 96 VLBW infants fed only MOM enterally during the first week. Feeding goals included provision of protein (>2.0) and lipids (1.0 g/kg/day) on the day of birth, advancing to 3.5 (protein) and 3.0 (lipid) g/kg/day within the first few days. Results: We found that 34% and 70% of infants did not meet protein and energy goals (of 3.5 g/kg/day and 90‐100 kcal/kg/day), respectively, at the end of the first week. Conclusions: Despite the adoption of more aggressive nutrition guidelines, most MOM‐fed VLBW infants remain undernourished at the end of the first week of life. Strategies to address these deficits may significantly impact the health outcomes of this vulnerable population. Grant Funding Source: Supported by CIHR (MOP#210093).