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 growthzscores.
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.
Serious morbidity may elevate nutrient requirements and affect adherence to feeding guidelines for very low birth weight (VLBW) infants. An understanding of factors affecting nutrient intakes of VLBW infants will facilitate development of strategies to improve nutrient provision. Our aim was to examine the impact of neonatal morbidity count on achieving recommended nutrient intakes in VLBW infants.VLBW infants enrolled in the Donor Milk for Improved Neurodevelopmental Outcomes trial (ISRCTN35317141, n = 363) were included. Serious morbidities and daily parenteral and enteral intakes were collected prospectively.Median intakes of infants with and without ≥1 morbidity met protein recommendations (3.5-4.5 g/kg/d) by week 2, although not maintained after week 4. Infants with ≥1 morbidity (vs without) were 2 weeks slower in achieving lipid (4.8-6.6 g/kg/d; week 4 vs 2) and energy (110-130 kcal/kg/d; week 5 vs 3) and 1 week slower in achieving carbohydrate recommendations (11.6-13.2 g/kg/d; week 4 vs 3). Adjusted hazard ratios of first achieving recommendations on any given day in infants with any 1 or 2 morbidities were 0.6 (95% confidence interval [CI], 0.5-0.9) and 0.6 (0.4-0.9), respectively, for protein; 0.5 (0.4-0.7) and 0.3 (0.2-0.5) for lipid; and 0.5 (0.4-0.7) and 0.3 (0.2-0.4) for energy.Morbidity is associated with a decreased likelihood of achieving lipid and consequently energy recommendations. This and the decline in protein intakes after the early neonatal period require further investigation to ensure optimal nutrition in this vulnerable population.
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).
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.