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

Jae H Kim, Gary Chan, Richard Schanler, Sharon Groh-Wargo, Barry Bloom, Reed Dimmit, Larry Williams, Geraldine Baggs, Bridget Barrett-Reis, Jae H Kim, Gary Chan, Richard Schanler, Sharon Groh-Wargo, Barry Bloom, Reed Dimmit, Larry Williams, Geraldine Baggs, Bridget Barrett-Reis

Abstract

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 · kg(-1) · 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 · kg(-1) · 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 · kg(-1) · day(-1).

Trial registration: ClinicalTrials.gov NCT01373073.

Conflict of interest statement

The authors report no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Disposition of subjects.
FIGURE 2
FIGURE 2
Evaluable analysis: A, weight (in grams); B, length (in centimeters); C, head circumference (in centimeters). A, Weight (in grams). Repeated measures analysis main effect, P = 0.036; post-hoc per time point analysis: SDAY 29, P = 0.024. B, Length (in centimeters). Repeated measures analysis main effect, P = 0.029; post-hoc per time point analysis: SDAY 22, P = 0.006, SDAY 29, P = 0.037. C, Head circumference (in centimeters).

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Source: PubMed

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