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
SN - 1745-6215
VL - 20
JO - Trials
JF - Trials
M1 - 279
ER -