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

Authors: HAIR, AMY - Children'S Nutrition Research Center (CNRC); BLANCO, CYNTHIA - University Of Texas Health Science Center; MOREIRA, ALVARO - University Of Texas Health Science Center; HAWTHORNE, KELI - Children'S Nutrition Research Center (CNRC); LEE, MARTIN - Prolacta Bioscience; RECHTMAN, DAVID - Prolacta Bioscience; ABRAMS, STEVEN - Children'S Nutrition Research Center (CNRC)

Submitted to: Journal of Pediatrics
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 7/1/2014
Publication Date: 11/3/2014
Citation: Hair, A.B., Blanco, C.L., Moreira, A.G., Hawthorne, K.M., Lee, M.L., Rechtman, D.J., Abrams, S.A. 2014. 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. Journal of Pediatrics. 165(5):915-920.

Interpretive Summary: Premature infants are at risk for slow growth after they are born. Sometimes infants need additional calories than is in human milk and human milk fortifiers to reach their optimal growth rate. We studied a novel supplement called human milk cream which is derived from donor human milk fat. We found that infants who received this supplement had improved weight gain and length gain compared to the standard feeding regimen. We found that the caloric content of human milk can vary and premature infants can benefit with improved growth by receiving a small amount of human milk cream supplement as part of an all human milk diet.

Technical Abstract: Our objective was 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). 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. 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. We concluded 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.