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

Nemours Children's Clinic · with Emory University · NCT04599010

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 0 mo–2 mo · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
40
US sites recruiting
2
Study start
September 26, 2024
Record last updated
May 27, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Dietary intervention

Conditions: Body Composition; Feeding; Difficult, Newborn; Nutrition Disorder, Infant

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Nemours Children's Hospital

    Orlando, FL 32827

    Site contact: Sreekanth Viswanathan · 407-697-7603 · sreekanth.viswanathan@nemours.org

  • Emory University

    Atlanta, GA 30329

    Site contact: Kera McNelis, MD · kmmcnel@emory.edu

Study contacts (from the official record)

  • Sreekanth Viswanathan, MD,MS · 4076977603 · sreekanth.viswanathan@nemours.org
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Role of Body Composition in Large for Gestational Age Infants… (NCT04599010) | Bored Studies