The feasibility of bovine colostrum as diet supplement for preterm infant has been proved. The project PreColos has provided solid proof on tolerance and feasibility and the results pave the way for the following larger trials.
Bovine colostrum is feasible as diet supplement for preterm infants
Bovine colostrum supplementation is well tolerated and raises enteral protein intake markedly in very premature infants during the first week of life. Bovine colostrum is thus feasible as novel, bioactive milk diet for preterm infants. These results are from the project PreColos, the first study on bovine colostrum as diet supplement for preterm infants.
Three-phase study
PreColos was designed as a three-phase study, with increasing number of participants per phase. In phase A, three infants was recruited consecutively to receive bovine colostrum as a supplement to standard feeding. In phase B, seven infants were recruited parallel, and in phase C 40 infants were recruited and radomized to either bovine colostrum or standard feeding.
The paper A stepwise, pilot study of bovine colostrum to supplement the first enteral feeding in preterm infants (PreColos): study protocol and initial results describes the study protocol and the results from Phase A and B (12 infants in Denmark and China). The paper concludes that bovine colostrum supplementation appeared well tolerated and resulted in high enteral protein intake.
Results from Phase C (40 infants in Denmark and China) were published in the paper Bovine colostrum for preterm infants in the first days of life: A randomized controlled pilot study. Phase C was an open-labeled randomized controlled pilot safety study. This study demonstrated that it is feasible to give bovine colostrum to extremely preterm infants. It also showed that bovine colostrum supplementation increases enteral protein intake without increasing feeding intolerance and without any apparent clinical adverse effects. Infants given bovine colostrum supplementation had elevated plasma tyrosine on day 7, likely related to their higher protein intake.
Read more about the project here on ClinicalTrials.gov: NCT02054091.
What now?
PreColos is a part of the NEOMUNE project, and was initiated in December 2016 and completed in January 2017. This feasibility pilot study enrolled 52 Danish and Chinese preterm infants. The aims was to investigate whether preterm infants can tolerate bovine colostrum as their first nutrition supplemented to mother's own milk.
The results from PreColos pave the way for the following larger trials using bovine colostrum as the first feed for preterm infants with insufficient access to mother’s own milk: PreColos-RCT and FortiColos (part of NEOCOL)