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. 2019 May 22;20(1):279.
doi: 10.1186/s13063-019-3367-7.

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

Agnethe M Ahnfeldt  1 , Nana Hyldig  2   3 , Yanqi Li  1 , Susanne Soendergaard Kappel  1   4 , Lise Aunsholdt  4 , Per T Sangild  1   5   4   2 , Gitte Zachariassen  6   7
Affiliations

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

Agnethe M Ahnfeldt et al. Trials. .

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 .

Keywords: Bovine colostrum; bovine colostrum-based fortifier; bovine milk-based fortifier; feeding intolerance; fortification of human milk; growth; human donor milk; late-onset sepsis; mother’s own milk; necrotizing enterocolitis; nutrition; very preterm infants.

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Conflict of interest statement

University of Copenhagen has filed a patent on the use of bovine colostrum for human infants (PCT/DK2013/050184) in collaboration with the company Biofiber Damino, which will be given an option to license the patent. PTS is listed as sole inventor, but has declined any share of potential revenue arising from commercial exploitation of such a patent. PTS is not part of any clinical work in any of the neonatal units in this study (e.g. inclusion, exclusion, information, randomisation or data collection). Other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow of participants and data collection in the FortiColos Study
Fig. 2
Fig. 2
SPIRIT figure for FortiColos showing the schedule of enrolment, interventions and assessments
See this image and copyright information in PMC

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