Growth and Tolerance of Preterm Infants Fed a New Extensively Hydrolyzed Liquid Human Milk Fortifier.
OBJECTIVE
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).
*University of California, San Diego-Rady Children's Hospital of San Diego, San Diego †University of Utah, Salt Lake City ‡Cohen Children's Medical Center of New York, New Hyde Park §Case Western Reserve University, MetroHealth Medical Center, Cleveland, OH ||Wesley Medical Center, Wichita, KS ¶University of Alabama, Birmingham #Abbott Nutrition, Columbus, OH.
Jae H
JH
Kim
Gary
G
Chan
Richard
R
Schanler
Sharon
S
Groh-Wargo
Barry
B
Bloom
Reed
R
Dimmit
Larry
L
Williams
Geraldine
G
Baggs
Bridget
B
Barrett-Reis
D001827:Body Height; D004044:Dietary Proteins / Q000009:adverse effects / Q000494:pharmacology*; D019587:Dietary Supplements; D002149:Energy Intake; D004750:Enteral Nutrition; D005260:Female; D005527:Food, Fortified; D006128:Growth / Q000187:drug effects; D006801:Humans; D006868:Hydrolysis; D041943:Infant Formula / Q000737:chemistry*; D007231:Infant, Newborn; D007234:Infant, Premature; D008297:Male; D008895:Milk, Human; D015430:Weight Gain
D004044:Dietary Proteins