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Original Investigation
July 2016

Effect of Donor Milk on Severe Infections and Mortality in Very Low-Birth-Weight InfantsThe Early Nutrition Study Randomized Clinical Trial

Author Affiliations
  • 1Department of Pediatrics, Emma Children’s Hospital–Academic Medical Center, Amsterdam, the Netherlands
  • 2Department of Pediatrics, VU University Medical Center, Amsterdam, the Netherlands
  • 3Department of Pediatrics, Radboud University Medical Center, Nijmegen, the Netherlands
  • 4Pediatric Clinical Research Office, Woman-Child Department, Academic Medical Center, Amsterdam, the Netherlands
  • 5Division of Neonatology, University Medical Center Groningen, Beatrix Children’s Hospital, University of Groningen, Groningen, the Netherlands
  • 6Department of Pediatrics, Erasmus Medical Center-Sophia Children’s Hospital, Rotterdam, the Netherlands
  • 7Department of Pediatrics, Isala Clinics, Zwolle, the Netherlands
JAMA Pediatr. 2016;170(7):654-661. doi:10.1001/jamapediatrics.2016.0183
Abstract

Importance  Infections and necrotizing enterocolitis, major causes of mortality and morbidity in preterm infants, are reduced in infants fed their own mother’s milk when compared with formula. When own mother’s milk is not available, human donor milk is considered a good alternative, albeit an expensive one. However, most infants at modern neonatal intensive care units are predominantly fed with own mother's milk. The benefits of add-on donor milk over formula are not clear.

Objective  To determine whether providing donor milk instead of formula as supplemental feeding whenever own mother’s milk is insufficiently available during the first 10 days of life reduces the incidence of serious infection, necrotizing enterocolitis, and mortality.

Design, Settings, and Participants  The Early Nutrition Study was a multicenter, double-blind randomized clinical trial in very low-birth-weight infants (birth weight <1500 g) admitted to 1 of 6 neonatal intensive care units in the Netherlands from March 30, 2012, through August 17, 2014. Intent-to-treat analysis was performed.

Interventions  Infants received pasteurized donor milk or preterm formula during the first 10 days of life if own mother’s milk was not (sufficiently) available.

Main Outcomes and Measures  The primary end point was cumulative occurrence of serious infection (sepsis or meningitis), necrotizing enterocolitis, or mortality during the first 60 days of life.

Results  A total of 930 infants were screened for inclusion; 557 were excluded, resulting in 373 infants (183 receiving donor milk and 190 receiving formula) who were evaluated by intent-to-treat analysis (median birth weight, 1066 g; mean gestational age, 28.4 weeks). Own mother’s milk comprised 89.1% and 84.5% of total mean intake during the intervention period for the donor milk and formula groups, respectively. The incidence of the combined outcome was not different (85 [44.7%] [formula] vs 77 [42.1%] [donor milk]; mean difference, 2.6%; 95% CI, −12.7% to 7.4%). The adjusted hazard ratio was 0.87 (95% CI, 0.63-1.19; P = .37).

Conclusions and Relevance  In the current study, pasteurized donor milk and preterm formula as supplemental feeding during the first 10 days of life yielded similar short-term outcomes in very low-birth-weight infants regarding safety and efficacy when own mother’s milk availability was insufficient. Future studies investigating longer duration of use of human donor milk on short-term and long-term outcomes are necessary.

Trial Registration  trialregister.nl Identifier: NTR3225

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