Trial reportJournal of pediatric gastroenterology and nutrition2015
Growth and Tolerance of Preterm Infants Fed a New Extensively Hydrolyzed Liquid Human Milk Fortifier.
Trial report in Journal of pediatric gastroenterology and nutrition, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 25 papers, 5 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Growth and Nutritional Status of Very Low Birth Weight Infants Fed a High Protein Exclusive Human Milk Diet
TITLE OF STUDY: Safety and Efficacy of a Novel Human Milk-based Human Milk Fortifier in Very Low Birth Weight Infants
Who cites it
25 citing papers in PubMed, 5 syntheses or guidelines pooled it, 57 citations in OpenAlex.
- High protein intake on later outcomes in preterm children: a systematic review and meta-analysis.Pediatric research · 2025Pooled it
- Comparison of different protein concentrations of human milk fortifier for promoting growth and neurological development in preterm infants.The Cochrane database of systematic reviews · 2020Pooled it
- Feeding Interventions for Infants with Growth Failure in the First Six Months of Life: A Systematic Review.Nutrients · 2020Pooled it
- Multi-nutrient fortification of human milk for preterm infants.The Cochrane database of systematic reviews · 2020Pooled it
- Milk feed osmolality and adverse events in newborn infants and animals: a systematic review.Archives of disease in childhood. Fetal and neonatal edition · 2019Pooled it
- Trial
- A novel human milk fortifier supports adequate growth in very low birth weight infants: a non-inferiority randomised controlled trial.Archives of disease in childhood. Fetal and neonatal edition · 2025Trial
- Trial
- Outbreak of Gastrointestinal Sepsis Associated with Bacillus cereus-Contaminated Human Milk Fortifier in Preterm Neonates.Indian pediatrics · 2026Article
- Narrative review of human milk fortifiers for preterm infants.Frontiers in pediatrics · 2026Review
- Improved Growth Velocity Using a New Liquid Human Milk Fortifier in Very Low Birth Weight Infants: A Multicenter, Retrospective Study.American journal of perinatology · 2025Article
- Freeze-Dried Donor Milk for Fortification of Mother's Own Milk in Preterm Infants: A Preliminary Observational Study.Nutrients · 2025Observational
- [Interpretation of key points from the "Expert Consensus on Diagnosis and Management of Neonatal Cow Milk Protein Allergy (2023)"].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2024Article
- Targeting optimal protein delivery in parenteral and enteral nutrition for preterm infants: a review of randomized, controlled trials.Journal of perinatology : official journal of the California Perinatal Association · 2024Review
- Human milk fortification and use of infant formulas to support growth in the neonatal intensive care unit.Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition · 2023Review
- Use of human milk and fortification in the NICU.Journal of perinatology : official journal of the California Perinatal Association · 2023Review
- Ultra-High Temperature Treatment and Storage of Infant Formula Induces Dietary Protein Modifications, Gut Dysfunction, and Inflammation in Preterm Pigs.Molecular nutrition & food research · 2022Article
- Review highlights the importance of donor human milk being available for very low birth weight infants.Acta paediatrica (Oslo, Norway : 1992) · 2022Review
- Effects of Formula Milk Feeding in Premature Infants: A Systematic Review.Children (Basel, Switzerland) · 2022Review
- Using Human Milk Fortifiers to Improve the Preoperative Nutritional Status of Infants With Non-restricted Ventricular Septal Defect.Frontiers in pediatrics · 2022Article
Corrections and comments
- Erratum issued
Authors and funding
9 authors at 8 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThis 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.
methodsThis 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.
resultsA 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.
conclusionsBoth 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).
Indexed as
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.