Actively Recruiting
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
Eligibility Criteria
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
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
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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