Bovine colostrum as a fortifier to human milk in very preterm infants - A randomized controlled trial (FortiColos).

Background: Human milk for very preterm infants need fortification for optimal growth and development but the optimal fortification product remains to be identified.

Aims: To investigate feasibility, safety and preliminary efficacy on growth and blood biochemistry when using intact bovine colostrum (BC) as a fortifier to human milk in very preterm infants.

Methods: In an open-label, multicenter, randomized controlled pilot trial (infants 26-31 weeks' gestation), mother's own milk or donor human milk was fortified with powdered BC (n = 115) or a conventional fortifier (CF, bovine-milk-based, n = 117) until 35 weeks' postmenstrual age.