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

  • 2023-05
  • Clinical nutrition (Edinburgh, Scotland) 42(5)
    • Agnethe May Ahnfeldt
    • Lise Aunsholt
    • Bo Moelholm Hansen
    • Bente Hoest
    • Valdís Jóhannsdóttir
    • Susanne Soendergaard Kappel
    • Anja Klamer
    • Sören Möller
    • Bertha Kanijo Moeller
    • Per Torp Sangild
    • Ann Lawaetz Skovgaard
    • Gerrit van Hall
    • Louise Dyrberg Vibede
    • Gitte Zachariassen

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 232
Population
232 very preterm infants (26-31 weeks' gestation)
Methods
Open-label, multicenter, randomized controlled pilot trial; human milk fortified with powdered bovine colostrum (BC) or conventional fortifier (CF) until 35 weeks' postmenstrual age
Blinding
Open-label
Duration
until 35 weeks' postmenstrual age
Funding
Unclear
  • Large Human Trial

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.

Research Insights

Adverse Events Reported

  • Bovine Colostrum→late-onset sepsis

    LOS (BC: 23/113 vs. CF: 14/116, p=0.08)

    Finding
    No significant difference
    Magnitude
    23/113 vs 14/116, p=0.08
    Significant
    No
  • Bovine Colostrum→necrotizing enterocolitis

    incidence of NEC (BC: 3/115 vs. CF: 5/117, p=0.72, unadjusted values)

    Finding
    No significant difference
    Magnitude
    3/115 vs 5/117, p=0.72
    Significant
    No
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