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

RecruitingNAAges 1 Week - 10 WeeksAllNemours Children's Clinic
NCT04599010 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Dietary intervention
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Where

2 sites
Nemours Children's Hospital
Orlando, United States
Emory University
Atlanta, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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