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

Recruiting now · Not applicable

Conditions studied: Body Composition, Feeding; Difficult, Newborn, Nutrition Disorder, Infant

In brief

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.

Key facts

Study ID

NCT04599010

Run by

Nemours Children's Clinic

People needed

40

Starts

2024-09-26

Expected to finish

2027-12-31

Last updated by the study team

2026-05-27

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Nemours Children's Hospital — Orlando, Florida, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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