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Formula with large, milk phospholipid-coated lipid droplets in late-moderate preterm infants: a double-blind RCT
Andreas Kakaroukas1,2, Marieke Abrahamse-Berkeveld3, Louise Hayes4
1Newcastle Neonatal Service, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals National Health Service (NHS) Foundation Trust, Newcastle upon Tyne, UK.
Insights
A new concept infant formula showed similar growth to standard formula in preterm infants. This formula is a safe alternative for parents choosing formula feeding for their late and moderate preterm infants.
Area of Science:
- Neonatal Nutrition
- Pediatric Gastroenterology
- Infant Growth and Development
Background:
- Limited evidence exists on optimal infant formula for late and moderate preterm (LMPT) infants when breastfeeding is not possible.
- Preterm infant nutrition is critical for growth and development.
- Novel infant formulas aim to mimic breast milk composition and benefits.
Purpose of the Study:
- To evaluate the growth, safety, and tolerance of a novel concept infant formula (IF) in LMPT infants.
- To demonstrate non-inferiority of daily weight gain compared to standard IF.
- To compare growth outcomes against a breastfed reference group.
Main Methods:
- A randomized controlled trial (RCT) involving LMPT infants.
- Infants were randomized to either concept IF (n=21) or standard IF (n=20) around term equivalent age.
- A reference group of 41 breastfed (BF) infants was included for comparison.
Main Results:
- Non-inferiority of daily weight gain could not be demonstrated due to low recruitment, but the concept formula was comparable to the breastfed group.
- Head circumference gain was larger in the concept formula group, though not statistically significant.
- Growth and body composition were similar between concept and breastfed groups; both formulas were well-tolerated.
Conclusions:
- The concept infant formula appears to be a safe alternative for LMPT infants when formula feeding is chosen.
- Further large-scale trials are necessary to confirm findings on head growth and body composition.
- This study provides preliminary evidence supporting the use of the novel formula in specific infant populations.
Background:
Limited evidence exists on the preferred feeding method when breastfeeding is not possible in late and moderate preterm (LMPT) infants. This RCT evaluates growth, safety, and tolerance of a concept infant formula (IF) with large, milk phospholipid-coated lipid droplets enriched in dairy lipids in LMPT infants with primary objective to demonstrate non-inferiority of daily weight gain from randomization to 3 months corrected age compared to a standard IF.
Methods:
LMPT infants were randomized before or around term equivalent age to either the concept (n = 21) or standard IF (n = 20). Forty-one breastfed (BF) infants served as reference.
Results:
Due to unintended low recruitment, non-inferiority in daily weight gain could not be demonstrated for the Concept compared to the Control group, but was compared to the BF group. Other outcomes were similar between the formula groups, except for an apparent larger head circumference gain in the Concept group. No apparent differences in growth and body composition outcomes were observed between the Concept and BF reference groups.
Conclusion:
This small-scale study suggests the concept IF is a safe alternative for parents who choose IF to feed their LMPT infant. Larger trials are needed to better determine impacts on head growth or body composition.
Impact:
In a small group of late and moderate preterm infants, growth from randomization until 3 months corrected age of infants fed with a concept infant formula with large, milk phospholipid-coated lipid droplets was not -significantly different from infants fed a standard infant formula. Infants in the Concept group had non-significant larger gain in head circumference compared to the Control group; larger trials are needed to confirm this finding. Both formulas were well-tolerated, with no differences in adverse events. The concept formula is potentially a safe alternative for parents of moderate to late preterm infants who choose to use formula milk.
