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Growth and Tolerance of Preterm Infants Fed a New Extensively Hydrolyzed Liquid Human Milk Fortifier.
J Pediatr Gastroenterol Nutr. 2015 Dec; 61(6):665-71.JP

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).

Authors+Show Affiliations

*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.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26488118

Citation

Kim, Jae H., et al. "Growth and Tolerance of Preterm Infants Fed a New Extensively Hydrolyzed Liquid Human Milk Fortifier." Journal of Pediatric Gastroenterology and Nutrition, vol. 61, no. 6, 2015, pp. 665-71.
Kim JH, Chan G, Schanler R, et al. Growth and Tolerance of Preterm Infants Fed a New Extensively Hydrolyzed Liquid Human Milk Fortifier. J Pediatr Gastroenterol Nutr. 2015;61(6):665-71.
Kim, J. H., Chan, G., Schanler, R., Groh-Wargo, S., Bloom, B., Dimmit, R., Williams, L., Baggs, G., & Barrett-Reis, B. (2015). Growth and Tolerance of Preterm Infants Fed a New Extensively Hydrolyzed Liquid Human Milk Fortifier. Journal of Pediatric Gastroenterology and Nutrition, 61(6), 665-71. https://doi.org/10.1097/MPG.0000000000001010
Kim JH, et al. Growth and Tolerance of Preterm Infants Fed a New Extensively Hydrolyzed Liquid Human Milk Fortifier. J Pediatr Gastroenterol Nutr. 2015;61(6):665-71. PubMed PMID: 26488118.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Growth and Tolerance of Preterm Infants Fed a New Extensively Hydrolyzed Liquid Human Milk Fortifier. AU - Kim,Jae H, AU - Chan,Gary, AU - Schanler,Richard, AU - Groh-Wargo,Sharon, AU - Bloom,Barry, AU - Dimmit,Reed, AU - Williams,Larry, AU - Baggs,Geraldine, AU - Barrett-Reis,Bridget, PY - 2015/10/22/entrez PY - 2015/10/22/pubmed PY - 2016/9/10/medline SP - 665 EP - 71 JF - Journal of pediatric gastroenterology and nutrition JO - J. Pediatr. Gastroenterol. Nutr. VL - 61 IS - 6 N2 - 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). SN - 1536-4801 UR - https://www.unboundmedicine.com/medline/citation/26488118/Growth_and_Tolerance_of_Preterm_Infants_Fed_a_New_Extensively_Hydrolyzed_Liquid_Human_Milk_Fortifier_ L2 - http://dx.doi.org/10.1097/MPG.0000000000001010 DB - PRIME DP - Unbound Medicine ER -