Growth and Tolerance of Preterm Infants Fed a New Extensively Hydrolyzed Liquid Human Milk Fortifier

摘要

Objectives: This study was a comparison of growth and tolerance in premature infants fed either standard powdered human milk fortifier ( HMF) or a newly formulated concentrated liquid that contained extensively hydrolyzed protein. Methods: This was an unblinded randomized controlled multicenter noninferiority study on preterm infants receiving human milk ( HM) supplemented with 2 randomly assigned HMFs, either concentrated liquid HMF containing extensively hydrolyzed protein ( LE- HMF) or a powdered intact protein HMF ( PI- HMF) as the control. The study population consisted of preterm infants <= 33 weeks who were enterally fed HM. Infants were studied from the first day of HM fortification until day 29 or hospital discharge, whichever came first. Results: A total of 147 preterm infants were enrolled. Noninferiority was observed in weight gain reported in the intent- to- treat ( ITT) analysis was 18.2 and 17.5 g center dot kg - 1 center dot day - 1 for the LE- HMF and PI- HMF groups, respectively. In an a priori defined subgroup of strict protocol followers ( n = 75), the infants fed LE- HMF achieved greater weight over time than those fed PI- HMF ( P = 0.036). The LE- HMF group achieved greater linear growth over time compared to the PI- HMF ( P = 0.029). The protein intake from fortified HM was significantly higher in the LE- HMF group compared with the PI- HMF group ( 3.9 vs 3.3 g center dot kg - 1 center dot day - 1, P< 0.0001). Both fortifiers were well tolerated with no significant differences in overall morbidity. Conclusions: Both fortifiers showed excellent weight gain ( grams per kilograms per day), tolerance, and low incidence of morbidity outcomes with the infants who were strict protocol followers fed LE- HMF having improved growth during the study. These data point to the safety and suitability of this new concentrated liquid HMF ( LE- HMF) in preterm infants. Growth with this fortifier closely matches the recent recommendations for a weight gain of > 18 g center dot kg-1 center dot day -1.