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Bovine colostrum as a fortifier to human milk in very preterm infants - A randomized controlled trial (FortiColos)
Agnethe May Ahnfeldt1, Lise Aunsholt2, Bo Moelholm Hansen3
1Section of Comparative Pediatrics and Nutrition, University of Copenhagen, Frederiksberg, Denmark.
Insights
Bovine colostrum (BC) as a human milk fortifier for very preterm infants showed similar growth outcomes compared to conventional fortifiers. However, BC fortification led to increased protein intake and elevated plasma amino acid levels, suggesting potential need for adjustments.
Area of Science:
- Neonatal nutrition
- Pediatric gastroenterology
- Biochemistry
Background:
- Human milk fortification is crucial for very preterm infants' growth and development.
- The optimal fortification product for human milk remains undetermined.
- Intact bovine colostrum (BC) is explored as a novel fortifier.
Purpose of the Study:
- To assess the feasibility, safety, and preliminary efficacy of using intact bovine colostrum (BC) to fortify human milk for very preterm infants.
- To evaluate growth parameters and blood biochemistry in infants receiving BC-fortified human milk.
- To compare outcomes with a conventional fortifier (CF).
Main Methods:
- A multicenter, randomized controlled pilot trial involving infants born between 26-31 weeks' gestation.
- Human milk was fortified with powdered BC (n=115) or a conventional bovine-milk-based fortifier (CF, n=117).
- Growth, clinical morbidities (NEC, LOS), and plasma amino acid levels were monitored until 35 weeks' postmenstrual age.
Main Results:
- No significant differences in birth weight, gestational age, or Z scores for weight, length, or head circumference were observed between BC and CF groups.
- Incidence of necrotizing enterocolitis (NEC) and late-onset sepsis (LOS) did not differ significantly between groups.
- Infants receiving BC fortification had higher protein intake and elevated plasma amino acid levels compared to the CF group.
Conclusions:
- Bovine colostrum (BC) fortification of human milk in very preterm infants resulted in comparable growth to conventional fortifiers.
- BC fortification led to increased protein intake and moderate increases in plasma amino acid levels.
- Modifications to protein composition and micronutrients in BC-based fortifiers may be necessary for optimal infant nutrition.
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. Fortifiers and additional micronutrients were added to human milk according to local guidelines to achieve optimal growth (additional protein up to +1.4 g protein/100 mL human milk). Anthropometry was recorded weekly. Clinical morbidities including necrotizing enterocolitis (NEC) and late-onset sepsis (LOS) were recorded. Clinical biochemistry included plasma amino acid (AA) levels to assess protein metabolic responses to the new fortifier.
Results:
A total of 232 infants, gestational age (GA) 28.5 ± 1.4 (weeks + days), fulfilled inclusion criteria. Birthweight, GA and delta Z scores from birth to end of intervention on weight, length or head circumference did not differ between groups, nor between the subgroups of small for gestational age infants. Likewise, incidence of NEC (BC: 3/115 vs. CF: 5/117, p = 0.72, unadjusted values), LOS (BC: 23/113 vs. CF: 14/116, p = 0.08) and other morbidities did not differ. BC infants received more protein than CF infants (+10%, p < 0.05) and showed several elevated AA levels (+10-40%, p < 0.05).
Conclusion:
Infants fortified with BC showed similar growth but received more protein and showed a moderate increase in plasma AA-levels, compared with CF. Adjustments in protein composition and micronutrients in BC-based fortifiers may be required to fully suit the needs for very preterm infants.
