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

Agnethe M. Ahnfeldt¹  Yanqi Li¹  Per T. Sangild²  Susanne Soendergaard Kappel³  Nana Hyldig⁴  Gitte Zachariassen⁵  Lise Aunsholdt⁶ 

[1] 0000 0001 0674 042X, grid.5254.6, Section of Comparative Pediatrics and Nutrition, IVH, University of Copenhagen, Frederiksberg, Denmark;0000 0001 0674 042X, grid.5254.6, Section of Comparative Pediatrics and Nutrition, IVH, University of Copenhagen, Frederiksberg, Denmark;0000 0004 0512 5013, grid.7143.1, Hans Christian Andersen Children’s Hospital, Odense University Hospital, Odense, Denmark;grid.475435.4, Department of Neonatology, Rigshospitalet, Copenhagen, Denmark;0000 0001 0728 0170, grid.10825.3e, University of Southern Denmark, Odense, Denmark;0000 0001 0674 042X, grid.5254.6, Section of Comparative Pediatrics and Nutrition, IVH, University of Copenhagen, Frederiksberg, Denmark;grid.475435.4, Department of Neonatology, Rigshospitalet, Copenhagen, Denmark;0000 0001 0728 0170, grid.10825.3e, University of Southern Denmark, Odense, Denmark;0000 0004 0512 5013, grid.7143.1, OPEN Odense Patient data Explorative Network, Odense University Hospital, Odense, Denmark;0000 0004 0512 5013, grid.7143.1, Hans Christian Andersen Children’s Hospital, Odense University Hospital, Odense, Denmark;0000 0001 0728 0170, grid.10825.3e, University of Southern Denmark, Odense, Denmark;grid.475435.4, Department of Neonatology, Rigshospitalet, Copenhagen, Denmark;

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

DOI  :  10.1186/s13063-019-3367-7

来源: publisher

【 摘 要 】

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.DiscussionThe 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.

【 授权许可】

CC BY