A Stepwise, Pilot Study of Bovine Colostrum to Supplement the First Enteral Feeding in Preterm Infants (Precolos):
Yanqi Li1, Sandra M Juhl2, Xuqiang Ye3
1Section of Comparative Pediatrics and Nutrition, University of Copenhagen , Frederiksberg , Denmark.
Insights
Intact bovine colostrum (BC) supplementation is a feasible and well-tolerated first feed for preterm infants when mother's own milk is limited. This pilot study showed promising results for growth and protein intake, paving the way for larger trials.
Area of Science:
- Neonatal Nutrition
- Pediatric Gastroenterology
- Immunology
Background:
- Optimal nutrition for preterm infants, especially with limited mother's own milk, remains a challenge.
- Intact bovine colostrum (BC) offers rich protein, growth factors, and immune components beneficial for gut health.
- Previous research has not fully explored BC as an initial feeding strategy for preterm neonates.
Purpose of the Study:
- To assess the feasibility and tolerability of using intact bovine colostrum (BC) as the primary nutrition source for preterm infants.
- To evaluate the safety and efficacy of BC supplementation in preterm neonates with insufficient access to mother's own milk.
- To establish the foundation for a larger randomized controlled trial on BC as a first feed.
Main Methods:
- A phased pilot study (phases A, B, C) involving preterm infants (birth weight 1000-1800g or GA 27-32 weeks).
- Phases A and B involved supplementation with BC, with phase C being a randomized controlled trial.
- Key assessments included feeding intolerance, growth, time to full enteral feeding, infections, NEC, plasma amino acids, and intestinal function.
Main Results:
- Seven Danish and five Chinese infants received BC, achieving high enteral protein intake (1.81-1.83 g/kg/day).
- Infant growth rates were within the normal range during the study period.
- No significant clinical adverse effects were noted, although transient hypertyrosinemia occurred in five infants.
Conclusions:
- Intact bovine colostrum (BC) supplementation appears to be a safe and well-tolerated initial feeding option for preterm infants.
- The study successfully demonstrated the feasibility of using BC, supporting its progression to a randomized phase.
- BC holds potential as a novel, bioactive milk diet for preterm infants, particularly those with limited mother's own milk access.
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.
