Trial reportJournal of pediatric gastroenterology and nutrition2017
Growth and Nutritional Biomarkers of Preterm Infants Fed a New Powdered Human Milk Fortifier: A Randomized Trial.
Trial report in Journal of pediatric gastroenterology and nutrition, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04478487 (TITLE OF STUDY), which is not on this map. Cited by 24 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
TITLE OF STUDY: Safety and Efficacy of a Novel Human Milk-based Human Milk Fortifier in Very Low Birth Weight Infants
Who cites it
24 citing papers in PubMed, 3 syntheses or guidelines pooled it, 40 citations in OpenAlex.
- 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
- Human Milk-Derived Fortifiers Compared with Bovine Milk-Derived Fortifiers in Preterm Infants: A Systematic Review and Meta-Analysis.Advances in nutrition (Bethesda, Md.) · 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
- 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
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- Comparative study of preterm infants fed new and existing human milk fortifiers showed favourable markers of gastrointestinal status.Acta paediatrica (Oslo, Norway : 1992) · 2020Trial
- Trial
- Trial
- FEEDSETUP: feeding difficulties spectrum evaluation and treatment up-to-date proposal.Jornal de pediatria · 2026Review
- Effect of Human Milk-Based Fortifier on Weight Gain and Morbidity Among Preterm Low Birth Weight Infants.Indian journal of pediatrics · 2026Article
- Narrative review of human milk fortifiers for preterm infants.Frontiers in pediatrics · 2026Review
- [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
- [Expert consensus on enteral nutrition management of preterm infants (2024)].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
- Using a new human milk fortifier to optimize human milk feeding among very preterm and/or very low birth weight infants: a multicenter study in China.BMC pediatrics · 2024Article
- Effects of two-stage preterm formulas on growth, nutritional biomarkers, and neurodevelopment in preterm infants.Frontiers in pediatrics · 2024Article
- Identification of Novel Biomarkers in Late Preterm Neonates with Respiratory Distress Syndrome (RDS) Using Urinary Metabolomic Analysis.Metabolites · 2023Article
- Use of human milk and fortification in the NICU.Journal of perinatology : official journal of the California Perinatal Association · 2023Review
- Review highlights the importance of donor human milk being available for very low birth weight infants.Acta paediatrica (Oslo, Norway : 1992) · 2022Review
- Evidence summary of human milk fortifier in preterm infants.Translational pediatrics · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 11 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe aim of this study was to assess growth and nutritional biomarkers of preterm infants fed human milk (HM) supplemented with a new powdered HM fortifier (nHMF) or a control HM fortifier (cHMF). The nHMF provides similar energy content, 16% more protein (partially hydrolyzed whey), and higher micronutrient levels than the cHMF, along with medium-chain triglycerides and docosahexaenoic acid.
methodsIn this controlled, multicenter, double-blind study, a sample of preterm infants ≤32 weeks or ≤1500 g were randomized to receive nHMF (n = 77) or cHMF (n = 76) for a minimum of 21 days. Weight gain was evaluated for noninferiority (margin = -1 g/day) and superiority (margin = 0 g/day). Nutritional status and gut inflammation were assessed by blood, urine, and fecal biochemistries. Adverse events were monitored.
resultsAdjusted mean weight gain (analysis of covariance) was 2.3 g/day greater in nHMF versus cHMF; the lower limit of the 95% CI (0.4 g/day) exceeded both noninferiority (P < 0.001) and superiority margins (P = 0.01). Weight gain rate (unadjusted) was 18.3 (nHMF) and 16.8 g · kg · day (cHMF) between study days 1 and 21 (D1-D21). Length and head circumference (HC) gains between D1 and D21 were not different. Adjusted weight-for-age z score at D21 and HC-for-age z score at week 40 corrected age were greater in nHMF versus cHMF (P = 0.013, P = 0.003 respectively). nHMF had higher serum blood urea nitrogen, pre-albumin, alkaline phosphatase, and calcium (all within normal ranges; all P ≤ 0.019) at D21 versus cHMF. Both HMFs were well tolerated with similar incidence of gastrointestinal adverse events.
conclusionsnHMF providing more protein and fat compared to a control fortifier is safe, well-tolerated, and improves the weight gain of preterm infants.
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Registered trials
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