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Original Investigation
November 8, 2016

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

Author Affiliations
  • 1Physiology and Experimental Medicine Program, The Hospital for Sick Children, Toronto, Ontario, Canada
  • 2Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada
  • 3Trillium Health Partners, Mississauga, Ontario, Canada
  • 4Evaluative and Clinical Sciences, Sunnybrook Research Institute, Toronto, Ontario, Canada
  • 5Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
  • 6Department of Clinical Dietetics, The Hospital for Sick Children, Toronto, Ontario, Canada
  • 7Department of Pediatrics, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
  • 8Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada
  • 9St. Michael’s Hospital and Li Ka Shing Knowledge Institute, Toronto, Ontario, Canada
  • 10Department of Neonatology, The Hospital for Sick Children, Toronto, Ontario, Canada
  • 11Department of Pediatrics, William Osler Health System, Brampton, Ontario, Canada
  • 12Department of Pediatrics, McMaster Children’s Hospital and McMaster University, Hamilton, Ontario, Canada
  • 13Department of Pediatrics, Mount Sinai Hospital, Toronto, Ontario, Canada
  • 14Department of Diagnostic Imaging, The Hospital for Sick Children, Toronto, Ontario, Canada
  • 15Department of Medical Imaging, University of Toronto, Toronto, Ontario, Canada
JAMA. 2016;316(18):1897-1905. doi:10.1001/jama.2016.16144
Key Points

Question  Does use of nutrient-enriched donor milk compared with preterm formula, as a supplement to mother’s milk during hospitalization, improve cognitive development of very low-birth-weight infants at 18 months’ corrected age?

Findings  In this randomized clinical trial of 363 infants, no statistically significant differences in cognitive composite scores on the Bayley Scales of Infant and Toddler Development, Third Edition were found between feeding groups after adjustment for recruitment center, birth weight group, percentage of total enteral feeds for each infant consumed as mother’s milk, and maternal education.

Meaning  If donor milk is used in a setting with high provision of mother’s milk, improved neurocognitive development should not be considered a treatment goal.

Abstract

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

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