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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.
Trials. 2019 May 22; 20(1):279.T

Abstract

BACKGROUND

Very 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/DESIGN

In 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 REGISTRATION

Registered retrospectively 25 May 2018 at ClinicalTrials.gov: NCT03537365 .

Authors+Show Affiliations

Section of Comparative Pediatrics and Nutrition, IVH, University of Copenhagen, Frederiksberg, Denmark.University of Southern Denmark, Odense, Denmark. OPEN Odense Patient data Explorative Network, Odense University Hospital, Odense, Denmark.Section of Comparative Pediatrics and Nutrition, IVH, University of Copenhagen, Frederiksberg, Denmark.Section of Comparative Pediatrics and Nutrition, IVH, University of Copenhagen, Frederiksberg, Denmark. Department of Neonatology, Rigshospitalet, Copenhagen, Denmark.Department of Neonatology, Rigshospitalet, Copenhagen, Denmark.Section of Comparative Pediatrics and Nutrition, IVH, University of Copenhagen, Frederiksberg, Denmark. Hans Christian Andersen Children's Hospital, Odense University Hospital, Odense, Denmark. Department of Neonatology, Rigshospitalet, Copenhagen, Denmark. University of Southern Denmark, Odense, Denmark.Hans Christian Andersen Children's Hospital, Odense University Hospital, Odense, Denmark. gitte.zachariassen@rsyd.dk. University of Southern Denmark, Odense, Denmark. gitte.zachariassen@rsyd.dk.

Pub Type(s)

Clinical Trial Protocol
Journal Article
Multicenter Study

Language

eng

PubMed ID

31118098

Citation

Ahnfeldt, Agnethe M., et al. "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." Trials, vol. 20, no. 1, 2019, p. 279.
Ahnfeldt AM, Hyldig N, Li Y, et al. 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. Trials. 2019;20(1):279.
Ahnfeldt, A. M., Hyldig, N., Li, Y., Kappel, S. S., Aunsholdt, L., Sangild, P. T., & Zachariassen, G. (2019). 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. Trials, 20(1), 279. https://doi.org/10.1186/s13063-019-3367-7
Ahnfeldt AM, et al. 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. Trials. 2019 May 22;20(1):279. PubMed PMID: 31118098.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Ahnfeldt,Agnethe M, AU - Hyldig,Nana, AU - Li,Yanqi, AU - Kappel,Susanne Soendergaard, AU - Aunsholdt,Lise, AU - Sangild,Per T, AU - Zachariassen,Gitte, Y1 - 2019/05/22/ PY - 2018/09/27/received PY - 2019/04/15/accepted PY - 2019/5/24/entrez PY - 2019/5/24/pubmed PY - 2019/12/24/medline KW - Bovine colostrum KW - bovine colostrum-based fortifier KW - bovine milk-based fortifier KW - feeding intolerance KW - fortification of human milk KW - growth KW - human donor milk KW - late-onset sepsis KW - mother’s own milk KW - necrotizing enterocolitis KW - nutrition KW - very preterm infants SP - 279 EP - 279 JF - Trials JO - Trials VL - 20 IS - 1 N2 - BACKGROUND: Very 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/DESIGN: In 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 REGISTRATION: Registered retrospectively 25 May 2018 at ClinicalTrials.gov: NCT03537365 . SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/31118098/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_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3367-7 DB - PRIME DP - Unbound Medicine ER -