Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty
Launched by NEMOURS CHILDREN'S CLINIC · Oct 21, 2020
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating how body composition affects the ability of large for gestational age (LGA) infants to feed orally. LGA infants are those who are larger than typical for their gestational age and may have extra body fat due to receiving more nutrients in the womb. Researchers believe that having too much fat can cause problems with feeding. The trial aims to see if adjusting the amount of fat-free mass (the portion of the body that isn’t fat, like muscles and organs) in the diet can help these infants feed better and take in more food.
To participate in this study, infants must be LGA and have difficulties feeding, born at least 35 weeks into pregnancy, and have a specific measurement indicating excess fat. Unfortunately, infants who need breathing support, have certain swallowing issues, or serious medical conditions cannot take part. If eligible, participants will receive a tailored feeding plan to see if it improves their feeding abilities. This research could help improve feeding outcomes for infants facing these challenges.
Gender
ALL
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
About Nemours Children's Clinic
Nemours Children's Clinic is a leading pediatric healthcare organization dedicated to enhancing the health and well-being of children through innovative clinical care, research, and education. As a prominent clinical trial sponsor, Nemours is committed to advancing pediatric medicine by conducting rigorous clinical trials that explore new treatments and therapies. The clinic's multidisciplinary team of experts collaborates closely with families and community partners to ensure that research initiatives are aligned with the unique needs of children. With a focus on safety, efficacy, and ethical standards, Nemours Children's Clinic aims to foster breakthroughs that will improve health outcomes for children and adolescents.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Atlanta, Georgia, United States
Cincinnati, Ohio, United States
Orlando, Florida, United States
Patients applied
Trial Officials
Sreekanth Viswanathan, MD
Principal Investigator
Nemours Children's Clinic
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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