Actively Recruiting

Phase Not Applicable
Age: 1Week - 10Weeks
All Genders
Healthy Volunteers
NCT04599010

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

Led by Nemours Children's Clinic · Updated on 2025-05-30

40

Participants Needed

2

Research Sites

126 weeks

Total Duration

On this page

Sponsors

N

Nemours Children's Clinic

Lead Sponsor

E

Emory University

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 1Week - 10Weeks
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Large for Gestational Age (LGA) infants with oral feeding difficulty
  • Born at 35 weeks gestation or later
  • Fat mass z-score greater than +1.0 based on body composition measurement
Not Eligible

You will not qualify if you...

  • Infants receiving any respiratory support
  • Infants requiring enteral feeding longer than 60 minutes due to hypoglycemia concerns
  • Unsafe swallowing function shown by videofluoroscopic swallow study (VFSS)
  • Presence of gastrointestinal surgical conditions
  • Significant neurological problems
  • Major congenital or genetic syndromes or anomalies

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Nemours Children's Hospital

Orlando, Florida, United States, 32827

Actively Recruiting

2

Emory University

Atlanta, Georgia, United States, 30329

Actively Recruiting

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Research Team

S

Sreekanth Viswanathan, MD,MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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