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Growth of late preterm infants fed nutrient-enriched formula to 120 days corrected age-A randomized controlled trial
Karen P Best1,2, Lisa N Yelland1,3, Carmel T Collins1,2
1Women and Kids Theme, South Australian Health and Medical Research Institute, Adelaide, SA, Australia.
Insights
Nutrient-enriched formula (NEF) did not significantly improve weight gain in late preterm infants compared to standard term formula (STF). However, NEF showed a reduced risk of infectious illness in these infants.
Area of Science:
- Neonatal nutrition
- Pediatric gastroenterology
- Infant growth and development
Background:
- Late preterm infants (34-37 weeks gestation) are at risk for growth challenges.
- Standard term formula (STF) is typically used, but nutrient-enriched options (NEF) are being explored.
- Understanding optimal nutrition for appropriate for gestational age (AGA) late preterm infants is crucial for long-term health.
Purpose of the Study:
- To compare the efficacy of nutrient-enriched formula (NEF) versus standard term formula (STF) on the rate of body weight gain in late preterm infants.
- To evaluate secondary outcomes including body composition, growth parameters, and adverse events.
- To assess the impact of NEF on infectious illness risk in this population.
Main Methods:
- A multi-center, randomized controlled trial involving late preterm infants (34-37 weeks gestation) appropriate for gestational age (AGA).
- Infants were randomized to receive either NEF (22 kcal/30 ml, enriched with protein, bovine milk fat globule membrane, vitamin D, butyrate) or STF (20 kcal/30 ml).
- An observational breastfed reference group (BFR) was included. Primary outcome was weight gain rate to 120 days corrected age (d/CA).
Main Results:
- The trial was terminated early due to recruitment challenges, with a reduced sample size (NEF: n=22, STF: n=18).
- No significant difference in the rate of body weight gain was observed between the NEF and STF groups at 120 d/CA (mean difference 1.77 g/day, P=0.31).
- A significant reduction in the risk of infectious illness was noted in the NEF group compared to the STF group at 120 d/CA (RR 0.37, P=0.02).
Conclusions:
- Nutrient-enriched formula (NEF) did not demonstrate a significant benefit over standard term formula (STF) for the rate of body weight gain in AGA late preterm infants.
- The findings suggest a potential protective effect of NEF against infectious illnesses in this vulnerable population.
- Results should be interpreted with caution due to the small sample size resulting from early trial termination.
Objectives:
We aimed to compare the effects of nutrient-enriched formula with standard term formula on rate of body weight gain of late preterm infants appropriately grown for gestational age.
Study Design:
A multi-center, randomized, controlled trial. Late preterm infants (34-37 weeks' gestation), with weight appropriate for gestational age (AGA), were randomized to nutrient enriched formula (NEF) with increased calories (22 kcal/30 ml) from protein, added bovine milk fat globule membrane, vitamin D and butyrate or standard term formula 20 kcal/30 ml (STF). Breastfed term infants were enrolled as an observational reference group (BFR). Primary outcome was rate of body weight gain from enrollment to 120 days corrected age (d/CA). Planned sample size was 100 infants per group. Secondary outcomes included body composition, weight, head circumference and length gain, and medically confirmed adverse events to 365 d/CA.
Results:
The trial was terminated early due to recruitment challenges and sample size was substantially reduced. 40 infants were randomized to NEF (n = 22) and STF (n = 18). 39 infants were enrolled in the BFR group. At 120 d/CA there was no evidence of a difference in weight gain between randomized groups (mean difference 1.77 g/day, 95% CI, -1.63 to 5.18, P = 0.31). Secondary outcomes showed a significant reduction in risk of infectious illness in the NEF group at 120 d/CA [relative risk 0.37 (95% CI, 0.16-0.85), P = 0.02].
Conclusion:
We saw no difference in rate of body weight gain between AGA late preterm infants fed NEF compared to STF. Results should be interpreted with caution due to small sample size.
Clinical Trial Registration:
The Australia New Zealand Clinical Trials Registry (ACTRN 12618000092291). "mailto:maria.makrides@sahmri.com" maria.makrides@sahmri.com.
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