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Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty

Pilot Randomized Controlled Trial Comparing FFM-indexed Feeding vs. Standard Feeding in LGA Infants With Oral Feeding Difficulty and Disproportionate Body Composition.

Who can join

1 Week – 10 Weeks · All sexes · Healthy volunteers welcome

Inclusion Criteria:

* LGA infants with oral feeding difficulty born at ≥ 35 weeks gestation, with FM z-score \> +1.0 in body composition measurement

Exclusion Criteria:

* Infants on any respiratory support, Infants on enteral feeding duration \> 60 minutes due to hypoglycemia concerns, videofluoroscopic swallow study (VFSS) demonstrating unsafe swallowing function, GI surgical conditions, significant neurological morbidities, and major congenital, genetic syndromes/anomalies

About the study

Large for Gestational Age (LGA) infants have excess fat-mass (FM) proportion secondary to prolonged in utero exposure to an energy-rich environment. Our preliminary data suggest that excess FM proportion can be associated with oral feeding delay and a potentially modifiable therapeutic target to improve oral feeding outcomes. The objective of this study is to determine the impact of a short-term Fat-free mass (FFM)-indexed feeding on the oral intake volumes in LGA infants with oral feeding difficulties.

What is being tested

• Dietary intervention (other)

Sponsor: Nemours Children's Clinic · Participants: 40 · Started: Sep 26, 2024

Contact the study team

• Sreekanth Viswanathan, MD,MS · Phone: 4076977603

Official record on ClinicalTrials.gov — NCT04599010

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.