NCT04599010 Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty
| NCT ID | NCT04599010 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nemours Children's Clinic |
| Condition | Body Composition |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-09-26 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-09-26 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Sreekanth Viswanathan, MD
PRINCIPAL INVESTIGATOR
Nemours Children's Clinic
Frequently Asked Questions
Who can join the NCT04599010 clinical trial?
This trial is open to participants of all sexes, aged 1 Week or older, up to 10 Weeks, studying Body Composition. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04599010 currently recruiting?
Yes, NCT04599010 is actively recruiting participants. Contact the research team at sreekanth.viswanathan@nemours.org for enrollment information.
Where is the NCT04599010 trial being conducted?
This trial is being conducted at Orlando, United States, Atlanta, United States.
Who is sponsoring the NCT04599010 clinical trial?
NCT04599010 is sponsored by Nemours Children's Clinic. The principal investigator is Sreekanth Viswanathan, MD at Nemours Children's Clinic. The trial plans to enroll 40 participants.