title: Effect of Donor Milk on Severe Infections and Mortality in Very Low-Birth-Weight Infants: The Early Nutrition Study Randomized Clinical Trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  Infants received pasteurized donor milk or preterm formula during the first 10 days of life if own mother's milk was not (sufficiently) available.
  
  
  
  The primary end point was cumulative occurrence of serious infection (sepsis or meningitis), necrotizing enterocolitis, or mortality during the first 60 days of life.
  
  
  
  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).
  
  
  
  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.
  
  
  
  trialregister.nl Identifier: NTR3225.
authors.affiliation: Department of Pediatrics, Emma Children's Hospital-Academic Medical Center, Amsterdam, the Netherlands2Department of Pediatrics, VU University Medical Center, Amsterdam, the Netherlands.
authors.forename: Willemijn E
authors.initials: WE
authors.lastname: Corpeleijn
authors.affiliation: Department of Pediatrics, VU University Medical Center, Amsterdam, the Netherlands.
authors.forename: Marita
authors.initials: M
authors.lastname: de Waard
authors.affiliation: Department of Pediatrics, Radboud University Medical Center, Nijmegen, the Netherlands.
authors.forename: Viola
authors.initials: V
authors.lastname: Christmann
authors.affiliation: Department of Pediatrics, Emma Children's Hospital-Academic Medical Center, Amsterdam, the Netherlands2Department of Pediatrics, VU University Medical Center, Amsterdam, the Netherlands.
authors.forename: Johannes B
authors.initials: JB
authors.lastname: van Goudoever
authors.affiliation: Pediatric Clinical Research Office, Woman-Child Department, Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: Marijke C
authors.initials: MC
authors.lastname: Jansen-van der Weide
authors.affiliation: Division of Neonatology, University Medical Center Groningen, Beatrix Children's Hospital, University of Groningen, Groningen, the Netherlands.
authors.forename: Elisabeth M W
authors.initials: EM
authors.lastname: Kooi
authors.affiliation: Division of Neonatology, University Medical Center Groningen, Beatrix Children's Hospital, University of Groningen, Groningen, the Netherlands.
authors.forename: Jan F
authors.initials: JF
authors.lastname: Koper
authors.affiliation: Department of Pediatrics, VU University Medical Center, Amsterdam, the Netherlands.
authors.forename: Stefanie M P
authors.initials: SM
authors.lastname: Kouwenhoven
authors.affiliation: Department of Pediatrics, VU University Medical Center, Amsterdam, the Netherlands.
authors.forename: Hendrik N
authors.initials: HN
authors.lastname: Lafeber
authors.affiliation: Department of Pediatrics, Emma Children's Hospital-Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: Elise
authors.initials: E
authors.lastname: Mank
authors.affiliation: Department of Pediatrics, Emma Children's Hospital-Academic Medical Center, Amsterdam, the Netherlands.
authors.forename: Letty
authors.initials: L
authors.lastname: van Toledo
authors.affiliation: Department of Pediatrics, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, the Netherlands.
authors.forename: Marijn J
authors.initials: MJ
authors.lastname: Vermeulen
authors.affiliation: Department of Pediatrics, VU University Medical Center, Amsterdam, the Netherlands6Department of Pediatrics, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, the Netherlands.
authors.forename: Ineke
authors.initials: I
authors.lastname: van Vliet
authors.affiliation: Department of Pediatrics, Isala Clinics, Zwolle, the Netherlands.
authors.forename: Diny
authors.initials: D
authors.lastname: van Zoeren-Grobben
mesh_terms: D004311:Double-Blind Method; D020345:Enterocolitis, Necrotizing / Q000453:epidemiology / Q000401:mortality / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D041943:Infant Formula; D007227:Infant Nutritional Physiological Phenomena; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000453:epidemiology / Q000401:mortality / Q000517:prevention & control*; D019102:Infant, Very Low Birth Weight; D057194:Intention to Treat Analysis; D008297:Male; D008581:Meningitis / Q000453:epidemiology / Q000401:mortality / Q000517:prevention & control*; D017784:Milk Banks; D008895:Milk, Human; D018805:Sepsis / Q000453:epidemiology / Q000401:mortality / Q000517:prevention & control*; D016896:Treatment Outcome