Impact of Body Composition on Feeding in Large for Gestational Age Infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates how body composition affects oral feeding difficulties in Large for Gestational Age (LGA) infants. Eligible infants will be randomly assigned to receive either a Fat-free mass (FFM)-indexed feeding regimen or standard feeding for up to two weeks. The FFM-indexed approach aims to optimize feeding volumes based on fat-free mass rather than total body weight. Body composition and appetite-regulating hormone levels will be measured at the beginning and end of the intervention, with follow-up assessments for growth and feeding difficulties until six months of age.

Why it matters

Who can join: the full rules

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

Where it's running

• Nemours Children's Hospital
  Orlando, Florida, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Sreekanth Viswanathan, MD — Nemours Children's Clinic
• Study coordinator: Sreekanth Viswanathan, MD,MS
• Email: sreekanth.viswanathan@nemours.org
• Phone: 4076977603

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.