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

J Pediatr. 2013 Dec;163(6):1592-1595.e1. doi: 10.1016/j.jpeds.2013.07.011. Epub 2013 Aug 20.


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.

Trial registration: ClinicalTrials.gov NCT00506584.

Keywords: BOV; Bovine milk–based preterm formula; HUM; Human milk fortifier; NEC; Necrotizing enterocolitis.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Breast Feeding*
  • Cattle
  • Double-Blind Method
  • Enterocolitis, Necrotizing / epidemiology
  • Female
  • Food, Formulated*
  • Humans
  • Infant Formula*
  • Infant, Extremely Premature*
  • Infant, Newborn
  • Male
  • Milk
  • Parenteral Nutrition / statistics & numerical data

Associated data

  • ClinicalTrials.gov/NCT00506584