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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?
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.
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.
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.
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.
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.
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.
isrctn.org Identifier: ISRCTN35317141
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Corresponding Author: Deborah L. O’Connor, PhD, RD, Department of Nutritional Sciences, University of Toronto, The Hospital for Sick Children, Room 327, Fitzgerald Bldg, 150 College St, Toronto, ON M5S 3E2, Canada (firstname.lastname@example.org).
Author Contributions: Drs O’Connor and Kiss had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: O’Connor, Gibbins, Asztalos, Kelly, Unger.
Acquisition, analysis, or interpretation of data: O’Connor, Gibbins, Kiss, Bando, Brennan-Donnan, Ng, Campbell, Vaz, Fusch, Church, Kelly, Ly, Daneman, Unger.
Drafting of the manuscript: O’Connor, Gibbins, Kiss, Brennan-Donnan, Unger.
Critical revision of the manuscript for important intellectual content: O’Connor, Gibbins, Bando, Brennan-Donnan, Ng, Campbell, Vaz, Fusch, Asztalos, Church, Kelly, Ly, Daneman, Unger.
Statistical analysis: O’Connor, Kiss.
Administrative, technical, or material support: Bando, Brennan-Donnan, Ng, Campbell, Fusch, Church, Kelly, Daneman, Unger.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Members of the GTA DoMINO Feeding Group: In addition to the authors, the GTA DoMINO Feding Group includes Andrea Nash, MSc, RD, and Sabrina Wong, MSc, RN (Sunnybrook Health Sciences Centre); Michael Jory, BSc, Joanne Rovet, PhD, and Christopher Tomlinson, PhD, MB (The Hospital for Sick Children); Kirsten Kotsopoulos, RD, and Karel O’Brien, MD (Mount Sinai Hospital); Anwar Asady, MRCPCH, Ann Bayliss, MD, and Sandra Gabriele, RD (Trillium Health Partners); Shirley Sit, MASc, MD, and Sue Ekserci, RD (Humber River Hospital); Mahmud AlMadani, MB (Lakeridge Health); Munesh Singh, MB (Markham Stouffville Hospital); Shaheen Doctor, MD (North York General Hospital); Debbie Stone, RN (Rogers Hixon Ontario Human Milk Bank); Karen Chang, MB (Rouge Valley Health System); Peter Azzopardi, MD (The Scarborough Hospital); David Gryn, MD (Mackenzie Health); Jelena Popovic, MD (Michael Garron Hospital); Debby Arts-Rodas, RD (St Joseph’s Health Centre); Carol Williams, RN, and Charmaine van Schaik, MSc, MD (Southlake Regional Health Centre); Ilona Burkot, RD, and Judy Gibson-Stoliar, RD (William Osler Health System).
Data and Safety Monitoring Committee: Frank Greer, MD, Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison (chair); Sharon Groh-Wargo, PhD, RD, Case Western Reserve University at MetroHealth Medical Center, Cleveland, Ohio; Ardythe Morrow, PhD, Center for Interdisciplinary Research in Human Milk and Lactation Global Health Center and Department of Pediatrics, University of Cincinnati, Cincinnati, Ohio.
Funding/Support: This work was funded by the Canadian Institutes of Health Research (MOP No. 102638) and the Ontario Ministry of Health and Long-Term Care (grant No. 06465).
Role of the Funders/Sponsors: The funding agencies had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Previous Presentations: This study was presented in part at the Hot Topics in Neonatology Conference; December 8, 2015; Washington, DC; and at the Pediatric Academic Societies Meeting; May 3, 2016; Baltimore, Maryland.
Additional Contributions: We wish to thank the study families for their participation and ongoing support of this work. We wish to acknowledge the Human Milk Banking Association of North America and specifically the Mother’s Milk Bank of Ohio and the NorthernStar Mothers’ Milk Bank in Calgary, Alberta, Canada, for providing the donor milk.
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