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Pilot Randomised Trial of Calibrated Formula Volumes to Optimise Growth in Infants at Risk for Overweight: The
Ian M Paul1, Bernardo L Horta2, Mina Desai3
1Penn State College of Medicine, Hershey, Pennsylvania, USA.
Background:
Formula feeding and having a mother with overweight are associated with overweight during infancy.
Objectives:
We sought to pilot test calibrated formula feeding guidance using age and weight specific intake recommendations to improve weight outcomes amongst at-risk infants.
Methods:
Exclusively formula fed newborns with birthweight ≥ 50th percentile delivered to mothers with pre-pregnancy body mass index (BMI) ≥ 25 kg/m2 were randomised to intervention and usual care groups. At monthly visits from 1 to 5 months, mothers of intervention group infants with weight-for-length (WFL) ≥ 75th percentile were advised to give 10% less daily formula than required based upon sex, age and weight. The primary outcome was conditional weight gain (CWG) between birth and 6 months. Secondary outcomes included WFL z-score and overweight (WFL ≥ 95th percentile) at 6 months, as well as growth trajectory.
Results:
Sixty infants were enrolled; 36 mothers (66.7%) had pre-pregnancy BMI ≥ 30. Seventeen (28.3%) withdrew before 6 months. At each assessment, a minority had WFL ≥ 75th percentile required to receive calibrated formula guidance. There were no group differences in CWG (intervention mean 0.27, 95% CI -0.20 to 0.75 vs. control mean -0.12, 95% CI -0.62 to 0.37; p = 0.25) or for secondary outcomes.
Conclusions:
Calibrated infant formula recommendations were not associated with growth outcomes.
Trial Registration:
Clinicaltrials.gov identifier: NCT05104073 (registered October 11, 2021).
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