ArticleTrials2019
FortiColos - a multicentre study using bovine colostrum as a fortifier to human milk in very preterm infants: study protocol for a randomised controlled pilot trial.
Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03537365 (Bovine Colostrum to Fortify Human Milk for Preterm Infants A Randomized, Controlled Pilot Trial), which is not on this map. Cited by 20 papers, 1 of them a synthesis 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.
Bovine Colostrum to Fortify Human Milk for Preterm Infants A Randomized, Controlled Pilot Trial
Who cites it
20 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.
- Impact of three mammalian milk-derived fortifiers on morbidity and mortality in preterm infants: a systematic review and network meta-analysis.International breastfeeding journal · 2025Pooled it
- Gut microbiota development in very preterm infants following fortification of human milk.mSystems · 2025Trial
- Trial
- Glucose-regulatory hormones and growth in very preterm infants fed fortified human milk.Pediatric research · 2024Trial
- Trial
- Plasma amino acids after human milk fortification and associations with growth in preterm infants.Pediatric research · 2026Article
- Parental Consent to a Neonatal Clinical Study: The Roles of Uncertainty, Burden of Sample Collection and Societal Expectations.Acta paediatrica (Oslo, Norway : 1992) · 2026Article
- Metabolomic profiling of colostrum bar for identification of functional compounds using high resolution mass spectroscopy.Journal of food science and technology · 2025Article
- Protein and energy digestibility in preterm infants fed fortified human milk.Journal of pediatric gastroenterology and nutrition · 2025Article
- COMMENTARY: Searching for biomarkers and regulators of growth in very preterm infants with new fortifiers.Pediatric research · 2024Article
- Review
- Insulin-like growth factor 1 associated with altered immune responses in preterm infants and pigs.Pediatric research · 2024Article
- Regulatory T Cells in Development and Prediction of Necrotizing Enterocolitis in Preterm Neonates: A Scoping Review.International journal of molecular sciences · 2022Article
- Fortification With Bovine Colostrum Enhances Antibacterial Activity of Human Milk.JPEN. Journal of parenteral and enteral nutrition · 2021Article
- Review
- Exocrine Pancreatic Maturation in Pre-term and Term Piglets Supplemented With Bovine Colostrum.Frontiers in nutrition · 2021Article
- Editorial: Immunity in Compromised Newborns.Frontiers in immunology · 2021Article
- Does Caesarean Section or Preterm Delivery Influence TGF-β2 Concentrations in Human Colostrum?Nutrients · 2020Article
- Radiographic Imaging to Evaluate Food Passage Rate in Preterm Piglets as a Model for Preterm Infants.Frontiers in pediatrics · 2020Article
- Bovine Colostrum Before or After Formula Feeding Improves Systemic Immune Protection and Gut Function in Newborn Preterm Pigs.Frontiers in immunology · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundVery preterm infants (< 32 weeks gestation) have a relatively high nutrient requirement for growth and development. The composition of human milk is often inadequate to ensure optimal growth so it is common to fortify human milk for very preterm infants with nutrient fortifiers based on bovine milk. However, there are concerns that bovine milk-based fortifiers may increase the risk of feeding intolerance, necrotizing enterocolitis and late-onset sepsis. We hypothesize that a bovine colostrum-based product is a suitable alternative to bovine milk-based products when used as a fortifier to human milk in very preterm infants. METHODS/
designIn an open-label multicentre randomised controlled pilot trial, 200 very preterm infants (26 + 0 to 30 + 6 weeks gestation at birth) will be randomly allocated to a bovine colostrum-based or a bovine milk-based fortifier added to mother's own milk and/or human donor milk. Outcomes are growth rate, incidence of necrotizing enterocolitis and late-onset sepsis, a series of paraclinical endpoints, and practical feasibility of using the novel fortifier for very preterm infants. DISCUSSION: The optimal enteral diet and feeding regimen for very preterm infants remain debated; this clinical trial will document the feasibility, safety and preliminary efficacy of using bovine colostrum, rich in nutrients and bioactive factors, as a novel fortifier for human milk to very preterm infants. Data on infant growth, metabolism, gut function and immunity will be assessed from clinical data as well as blood and stool samples.
trial registrationRegistered retrospectively 25 May 2018 at ClinicalTrials.gov: NCT03537365 .
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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.