What this study is
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.
What's being tested
- Dietary intervention
Intervention · OTHER
energy-restricted diet appropriate for resting metabolic rate using FFM as proxy
Study details
- Official title
- Pilot Randomized Controlled Trial Comparing FFM-indexed Feeding vs. Standard Feeding in LGA Infants With Oral Feeding Difficulty and Disproportionate Body Composition.
- Sponsor
- Nemours Children's Clinic
- Conditions
- Body Composition · Feeding; Difficult, Newborn · Nutrition Disorder, Infant
- Enrolling
- 40 people
- Starts
- 2024-09-26
- Est. completion
- 2027-12-31
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 1 Week – 10 WeeksSex ALLHealthy volunteers AcceptedYou may qualify if
- LGA infants with oral feeding difficulty born at ≥ 35 weeks gestation, with FM z-score > +1.0 in body composition measurement
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openNemours Children's Hospital
Orlando, Florida, United States
- Sreekanth Viswanathan · Contact407-697-7603sreekanth.viswanathan@nemours.org
Recruiting- Recruiting
Study team
Sponsor
Nemours Children's Clinic
Study ID 871760
Principal investigator
Sreekanth Viswanathan, MD
Nemours Children's Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.