TY - JOUR

T1 - FortiColos - A multicentre study using bovine colostrum as a fortifier to human milk in very preterm infants

T2 - 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

PY - 2019

Y1 - 2019

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.

AB - 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.

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

U2 - 10.1186/s13063-019-3367-7

DO - 10.1186/s13063-019-3367-7

M3 - Journal article

C2 - 31118098

AN - SCOPUS:85066495982

VL - 20

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 279

ER -