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ARS Home » Plains Area » Houston, Texas » Children's Nutrition Research Center » Research » Publications at this Location » Publication #301612
Title: Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants

Author
item CRISTOFALO, ELIZABETH - Johns Hopkins University School Of Medicine
item SCHANLER, RICHARD - Cohen Children'S Medical Center Of New York
item BLANCO, CYNTHIA - University Of Texas Health Science Center
item SULLIVAN, SANDRA - University Of Florida
item TRAWOEGER, RUDOLF - Innsbruck Medical University
item KIECHL-KOHLENDORFER, URSULA - Innsbruck Medical University
item DUDELL, GOLDE - Children'S Hospital Oakland Research Institute
item RECHTMAN, DAVID - Prolacta Bioscience
item LEE, MARTIN - Prolacta Bioscience
item LUCAS, ALAN - Mrc Human Nutrition Research
item ABRAMS, STEVEN - Children'S Nutrition Research Center (CNRC)

Submitted to: Journal of Pediatrics
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 7/3/2013
Publication Date: 12/1/2013
Citation: Cristofalo, E.A., Schanler, R.J., Blanco, C.L., Sullivan, S., Trawoeger, R., Kiechl-Kohlendorfer, U., Dudell, G., Rechtman, D.J., Lee, M.L., Lucas, A., Abrams, S. 2013. Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants. Journal of Pediatrics. 163(6):1592-1595.

Interpretive Summary: We participated as part of a multcenter trail to see how preterm babies grew and whether they were healthier when they received a diet in which they only got human milk. The study was done at Ben Taub General Hospital as one of 12 sites around the country. We found that in extremely preterm infants given exclusive diets of preterm formula vs human milk, there was a significantly greater duration of intravenous nutrition and higher rate of bowel damage (called necrotizing enterocolitis) in infants receiving preterm formula. This trial supports the use of an exclusive human milk diet to feed extremely preterm infants in the neonatal intensive care unit.

Technical Abstract: Our objective was 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. This was conducted as a 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). 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. 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.