Clinical Trial

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

Recruiting
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Summary
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.
Protocol Amendment History 18 amendments
This ClinicalTrials.gov record has been amended 18 times since 2020-10-21; most recent amendment 2026-05-22.
Status change: Not Yet Recruiting → Recruiting 2024-08-27
Trial Details
NCT Number NCT04599010
Lead Sponsor Nemours Children's Clinic
Collaborators: Emory University
Conditions Body Composition, Feeding; Difficult, Newborn, Nutrition Disorder, Infant
Enrollment 40 participants
Start Date 2024-09-26
Primary Completion 2027-07-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-27