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

NCT04599010 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-30

No results posted yet for this study

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.

Conditions

  • Body Composition
  • Feeding; Difficult, Newborn
  • Nutrition Disorder, Infant

Interventions

OTHER

Dietary intervention

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

Sponsors & Collaborators

  • Emory University

    collaborator OTHER

  • Nemours Children's Clinic

    lead OTHER

Principal Investigators

  • Sreekanth Viswanathan, MD · Nemours Children's Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Week
Max Age
10 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-26
Primary Completion
2026-08-31
Completion
2027-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04599010 on ClinicalTrials.gov