title: Randomized trial of human milk cream as a supplement to standard fortification of an exclusive human milk-based diet in infants 750-1250 g birth weight.
abstract: OBJECTIVE
  To evaluate whether premature infants who received an exclusive human milk (HM)-based diet and a HM-derived cream supplement (cream) would have weight gain (g/kg/d) at least as good as infants receiving a standard feeding regimen (control).
  
  
  METHODS
  In a prospective noninferiority, randomized, unmasked study, infants with a birth weight 750-1250 g were randomly assigned to the control or cream group. The control group received mother's own milk or donor HM with donor HM-derived fortifier. The cream group received a HM-derived cream supplement if the energy density of the HM tested <20 kcal/oz using a near infrared HM analyzer. Infants were continued on the protocol until 36 weeks postmenstrual age. Primary outcomes included growth velocities and amount of donor HM-derived fortifier used. The hypothesis of noninferiority was established if the lower bound of the one-sided 95% CI for the difference in weight velocities exceeded -3 g/kg/day.
  
  
  RESULTS
  There were no differences between groups in baseline demographics for the 78 infants studied except racial distribution (P = .02). The cream group (n = 39) had superior weight (14.0 ± 2.5 vs 12.4 ± 3.0 g/kg/d, P = .03) and length (1.03 ± 0.33 vs 0.83 ± 0.41 cm/wk, P = .02) velocity compared with the control group (n = 39). There were no significant differences in amount of fortifier used between study groups. The 1-sided 95% lower bound of the CI for the difference in mean velocity (cream-control) was 0.38 g/kg/d.
  
  
  CONCLUSIONS
  Premature infants who received HM-derived cream to fortified HM had improved weight and length velocity compared with the control group. HM-derived cream should be considered an adjunctive supplement to an exclusive HM-based diet to improve growth rates in premature infants.
authors.affiliation: US Department of Agriculture (USDA)/Agricultural Research Service (ARS), Children's Nutrition Research Center, Section of Neonatology, Department of Pediatrics, Baylor College of Medicine, Texas Children's Hospital, Houston, TX. Electronic address: abhair@texaschildrens.org.
authors.forename: Amy B
authors.initials: AB
authors.lastname: Hair
authors.affiliation: Department of Pediatrics, University of Texas Health Science Center, San Antonio, TX.
authors.forename: Cynthia L
authors.initials: CL
authors.lastname: Blanco
authors.affiliation: Department of Pediatrics, University of Texas Health Science Center, San Antonio, TX.
authors.forename: Alvaro G
authors.initials: AG
authors.lastname: Moreira
authors.affiliation: US Department of Agriculture (USDA)/Agricultural Research Service (ARS), Children's Nutrition Research Center, Section of Neonatology, Department of Pediatrics, Baylor College of Medicine, Texas Children's Hospital, Houston, TX.
authors.forename: Keli M
authors.initials: KM
authors.lastname: Hawthorne
authors.affiliation: Prolacta Bioscience, Industry, CA.
authors.forename: Martin L
authors.initials: ML
authors.lastname: Lee
authors.affiliation: Prolacta Bioscience, Industry, CA.
authors.forename: David J
authors.initials: DJ
authors.lastname: Rechtman
authors.affiliation: US Department of Agriculture (USDA)/Agricultural Research Service (ARS), Children's Nutrition Research Center, Section of Neonatology, Department of Pediatrics, Baylor College of Medicine, Texas Children's Hospital, Houston, TX.
authors.forename: Steven A
authors.initials: SA
authors.lastname: Abrams
mesh_terms: D001724:Birth Weight; D001835:Body Weight; D019587:Dietary Supplements; D005260:Female; D005527:Food, Fortified; D006801:Humans; D007223:Infant; D007234:Infant, Premature / Q000254:growth & development*; D019102:Infant, Very Low Birth Weight / Q000254:growth & development*; D008297:Male; D008895:Milk, Human / Q000502:physiology*; D011446:Prospective Studies; D015430:Weight Gain / Q000502:physiology*