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Study on Body Composition and Feeding in Large for Gestational Age Infants

This study is looking at how a baby's body composition (the amount of fat versus lean mass) might affect their ability to feed by mouth. Specifically, it's for infants born larger than average for their gestational age (LGA) who are having trouble feeding. Researchers believe that having too much body fat might be linked to these feeding difficulties. The study will compare an "FFM-indexed feeding" plan, which adjusts feeding amounts based on a baby's lean body mass, to standard feeding practices. The main goal is to see if this special feeding plan helps babies learn to feed independently by mouth sooner. You might be able to join if your baby is 1 to 10 weeks old, was born at 35 weeks or more, is LGA with a high fat mass, and has oral feeding difficulties. The study status is currently unclear.

Study design
This is an interventional study planning to enroll 40 participants. Eligible infants will be randomly assigned to receive either the FFM-indexed feeding or standard feeding.
What's involved
Eligible infants will receive either the FFM-indexed feeding or standard feeding for up to 2 weeks. Body composition and hormone levels will be measured at the start and end of this 2-week period.
Compensation
Not stated in the trial record.
Follow-up
Infants will be followed for clinical and growth outcomes until they leave the neonatal intensive care unit (NICU) and through 6 months of age.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04599010

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

Recruiting
NAAges 1–10InterventionalTreatment
Nemours Children's Clinic
~40 participants
Updated 2026-05-27 on ClinicalTrials.gov
What's tested:Dietary intervention

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time from study entry to independent oral feeding
Measured over Before or at NICU-discharge

Conditions

Body Composition
Feeding; Difficult, Newborn
Nutrition Disorder, Infant

Explore related trials

Feeding ProblemLarge for Gestational Age

NCT04599010

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Emory University

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • Nemours Children's Hospital

    Orlando, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sreekanth Viswanathan, MD · PRINCIPAL_INVESTIGATOR · Nemours Children's Clinic

Who to contact

Sreekanth Viswanathan, MD,MS
[email protected]
4076977603
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Time from study entry to independent oral feedingBefore or at NICU-discharge

    full oral feeding defined as 120 ml/kg/d without tube feeding for 2 consecutive days