Effect of Supplemental Donor Human Milk Compared With Preterm Formula on Neurodevelopment of Very Low-Birth-Weight Infants at 18 Months: A Randomized Clinical Trial.

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 Participants: In 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 Measures: The 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. Results: Of 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. Trial Registration: isrctn.org Identifier: ISRCTN35317141.

How Close Are We to Achieving Energy and Nutrient Goals for Very Low Birth Weight Infants in the First Week?

BACKGROUND: Emerging evidence suggests intakes of protein and energy as early as the first week of life in preterm very low birth weight (VLBW) infants are associated with improved neurodevelopment. In response, many neonatal intensive care units (NICUs) have launched new, more aggressive early feeding guidelines. The aim of this study was to evaluate enteral and parenteral energy and macronutrient intakes during the first postnatal week in VLBW infants admitted to NICUs that have introduced more aggressive early feeding guidelines. MATERIALS AND METHODS: Estimated energy and macronutrient intakes were prospectively collected from VLBW infants fed exclusively mother's own milk and/or parenteral nutrition and compared with expert recommendations. Days to reach full enteral feeds (150 mL/kg/d) and discharge anthropometrics were examined. RESULTS: By days 6 and 7, median protein and lipid intakes, respectively, reached recommended values (3.5 and 3.0 g/kg/d). However, by day 8, many infants remained below recommended intakes for protein (34%), lipid (34%), carbohydrate (68%), and energy (71%). Late-onset sepsis was associated with a decreased likelihood of reaching full enteral feeds on any given day (hazard ratio, 0.2; 95% confidence interval, 0.1-0.5; P ≤ .0009). There was no significant relationship between week 1 nutrient intakes and anthropometrics at discharge. CONCLUSION: 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.