Impact of Body Composition on Feeding in Large for Gestational Age Infants
Pilot Randomized Controlled Trial Comparing FFM-indexed Feeding vs. Standard Feeding in LGA Infants With Oral Feeding Difficulty and Disproportionate Body Composition.
This study is testing if a special feeding plan based on body composition can help Large for Gestational Age infants with feeding difficulties.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 1 Week to 10 Weeks |
| Sex | All |
| Sponsor | Nemours Children's Clinic Academic / other |
| Locations | 2 sites (Orlando, Florida and 1 other locations) |
| Trial ID | NCT04599010 on ClinicalTrials.gov |
What this trial studies
This study investigates how body composition affects oral feeding difficulties in Large for Gestational Age (LGA) infants. Eligible infants will be randomly assigned to receive either a Fat-free mass (FFM)-indexed feeding regimen or standard feeding for up to two weeks. The FFM-indexed approach aims to optimize feeding volumes based on fat-free mass rather than total body weight. Body composition and appetite-regulating hormone levels will be measured at the beginning and end of the intervention, with follow-up assessments for growth and feeding difficulties until six months of age.
Who should consider this trial
Good fit: Ideal candidates are LGA infants born at or after 35 weeks gestation who exhibit oral feeding difficulties and have a fat mass z-score greater than +1.0.
Not a fit: Patients who are on respiratory support, have significant neurological morbidities, or have major congenital anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve oral feeding outcomes for LGA infants, potentially reducing feeding difficulties and enhancing growth.
How similar studies have performed: While this specific approach is innovative, similar studies have shown promise in addressing feeding difficulties in infants through tailored nutritional interventions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Orlando, Florida and 1 other locations
- Nemours Children's Hospital — Orlando, Florida, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Sreekanth Viswanathan, MD — Nemours Children's Clinic
- Study coordinator: Sreekanth Viswanathan, MD,MS
- Email: sreekanth.viswanathan@nemours.org
- Phone: 4076977603
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.