RecruitingNot ApplicableNCT04599010

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.


Sponsor

Nemours Children's Clinic

Enrollment

40 participants

Start Date

Sep 26, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 WeekMax Age: 10 Weeks

Plain Language Summary

Simplified for easier understanding

This study investigates why some large-for-gestational-age (LGA) infants — babies born bigger than expected — have difficulty feeding by mouth. Oral feeding problems are common in these babies but poorly understood. Researchers believe that excess body fat measured by body composition testing may affect the baby's oral feeding ability and metabolism. The study uses safe, non-invasive methods to measure fat and lean mass in LGA babies and relates this to their feeding performance. You may be eligible if: - Your baby is large-for-gestational-age (LGA) and was born at 35 weeks or later - Your baby has oral feeding difficulty - Your baby's body composition shows a fat mass z-score above +1.0 (measured by air displacement plethysmography) You may NOT be eligible if: - Your baby requires respiratory support - Your baby needs tube feeding for more than 60 minutes per session due to blood sugar concerns - A swallow study (VFSS) has shown unsafe swallowing - Your baby has a surgical GI condition, significant neurological problem, or major genetic/congenital anomaly Talk to your neonatologist or neonatal feeding team if your large newborn is struggling to feed by mouth and you want to understand how body composition may be affecting feeding outcomes.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERDietary intervention

energy-restricted diet appropriate for resting metabolic rate using FFM as proxy


Locations(2)

Nemours Children's Hospital

Orlando, Florida, United States

Emory University

Atlanta, Georgia, United States

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NCT04599010


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