A Stepwise, Pilot Study of Bovine Colostrum to Supplement the First Enteral Feeding in Preterm Infants (Precolos):Study Protocol and Initial Results

STUDY PROTOCOL: The optimal feeding for preterm infants during the first weeks is still debated, especially when mother’s own milk is lacking or limited. Intact bovine colostrum (BC) contains high amounts of protein, growth factors, and immuno-regulatory components that may benefit protein intake and gut maturation. We designed a pilot study to investigate the feasibility and tolerability of BC as the first nutrition for preterm infants. The study was designed into three phases (A, B, and C) and recruited infants with birth weights of 1,000–1,800 g (China) or gestational ages (GAs) of 27 + 0 to 32 + 6 weeks (Denmark). In phase A, three infants were recruited consecutively to receive BC as a supplement to standard feeding. In phase B, seven infants were recruited in parallel. In phase C (not yet complete), 40 infants will be randomized to BC or standard feeding. Feeding intolerance, growth, time to full enteral feeding, serious infections/NEC, plasma amino acid profile, blood biochemistry, and intestinal functions are assessed. This paper presents the study protocol and results from phases A and B. RESULTS: Seven Danish and five Chinese infants received 22 ± 11 and 22 ± 6 ml·kg(−1)·day(−1) BC for a mean of 7 ± 3 and 7 ± 1 days which provided 1.81 ± 0.89 and 1.83 ± 0.52 g·kg(−1)·day(−1) protein, respectively. Growth rates until 37 weeks or discharge were in the normal range (11.8 ± 0.9 and 12.9 ± 2.7 g·kg(−1)·day(−1) in Denmark and China, respectively). No clinical adverse effects were observed. Five infants showed a transient hypertyrosinemia on day 7 of life. DISCUSSION AND CONCLUSION: The three-phased study design was used to proceed with caution as this is the first trial to investigate intact BC as the first feed for preterm infants. BC supplementation appeared well tolerated and resulted in high enteral protein intake. Based on the safety evaluation of phases A and B, the randomized phase C has been initiated. When complete, the Precolos trial will document whether it is feasible to use BC as a novel, bioactive milk diet for preterm infants. Our trial paves the way for a larger randomized controlled trial on using BC as the first feed for preterm infants with insufficient access to mother’s own milk

Bovine Colostrum for Preterm Infants in the First Days of Life:A Randomized Controlled Pilot Trial

Mother's own milk (MM) is the best nutrition for newborn preterm infants, but is often limited in supply just after birth. Pasteurized human donor milk (DM), and especially preterm infant formula (IF) are less optimal diets than MM. We hypothesized that it is feasible to use bovine colostrum (BC), the first milk from cows, as a supplement to MM, during the first weeks after preterm birth. In an open-label, randomized, controlled pilot safety trial, supplementation of MM with BC was compared with DM supplementation (Danish unit) or IF supplementation (Chinese unit). If MM was limited or lacking, BC, DM or IF were given according to local feeding guidelines during the first 14 days of life. Forty infants were included and randomized in Denmark and in China, with gestational ages 29.9 ± 0.4 and 31.1 ± 0.2 weeks, respectively. Infants supplemented with BC received more enteral protein (P  < 0.05) and tended to reach full enteral feeding earlier (China only). Eight infants fed BC showed a temporary elevation in plasma tyrosine on day 7, versus 2 infants in the DM/IF groups. There were no differences between diet groups in feeding intolerance or clinical adverse events. Our results indicate that it is feasible to use BC as a supplement to MM during the first weeks of life to increase enteral protein intake in preterm infants. Plasma tyrosine levels may be a good marker for excessive protein intake. A larger randomized trial is required to test the safety and possible short- and long-term clinical benefits of BC supplementation during the first weeks of life for preterm infant