Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants

Elizabeth A. Cristofalo, Richard J. Schanler, Cynthia L. Blanco, Sandra Sullivan, Rudolf Trawoeger, Ursula Kiechl-Kohlendorfer, Golde Dudell, David J. Rechtman, Martin L. Lee, Alan Lucas, Steven Abrams

Research output: Contribution to journalArticlepeer-review

381 Scopus citations


Objective To compare the duration of parenteral nutrition, growth, and morbidity in extremely premature infants fed exclusive diets of either bovine milk-based preterm formula (BOV) or donor human milk and human milk-based human milk fortifier (HUM), in a randomized trial of formula vs human milk. Study design Multicenter randomized controlled trial. The authors studied extremely preterm infants whose mothers did not provide their milk. Infants were fed either BOV or an exclusive human milk diet of pasteurized donor human milk and HUM. The major outcome was duration of parenteral nutrition. Secondary outcomes were growth, respiratory support, and necrotizing enterocolitis (NEC). Results Birth weight (983 vs 996 g) and gestational age (27.5 vs 27.7 wk), in BOV and HUM, respectively, were similar. There was a significant difference in median parenteral nutrition days: 36 vs 27, in BOV vs HUM, respectively (P =.04). The incidence of NEC in BOV was 21% (5 cases) vs 3% in HUM (1 case), P =.08; surgical NEC was significantly higher in BOV (4 cases) than HUM (0 cases), P =.04. Conclusions In extremely preterm infants given exclusive diets of preterm formula vs human milk, there was a significantly greater duration of parenteral nutrition and higher rate of surgical NEC in infants receiving preterm formula. This trial supports the use of an exclusive human milk diet to nourish extremely preterm infants in the neonatal intensive care unit.

Original languageEnglish (US)
Pages (from-to)1592-1595.e1
JournalJournal of Pediatrics
Issue number6
StatePublished - Dec 2013

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health


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