RECRUITING

Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pilot Randomized Controlled Trial Comparing FFM-indexed Feeding vs. Standard Feeding in LGA Infants With Oral Feeding Difficulty and Disproportionate Body Composition.

Quick Facts

Study Start:2024-08-27
Study Completion:2026-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04599010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Week to 10 Weeks
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * LGA infants with oral feeding difficulty born at ≥ 35 weeks gestation, with FM z-score \> +1.0 in body composition measurement
  1. * 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

Contacts and Locations

Study Contact

Sreekanth Viswanathan, MD,MS
CONTACT
4076977603
sreekanth.viswanathan@nemours.org

Principal Investigator

Sreekanth Viswanathan, MD
PRINCIPAL_INVESTIGATOR
Nemours Children's Clinic

Study Locations (Sites)

Nemours Children's Hospital
Orlando, Florida, 32827
United States
Emory University
Atlanta, Georgia, 30329
United States

Collaborators and Investigators

Sponsor: Nemours Children's Clinic

  • Sreekanth Viswanathan, MD, PRINCIPAL_INVESTIGATOR, Nemours Children's Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-27
Study Completion Date2026-06-01

Study Record Updates

Study Start Date2024-08-27
Study Completion Date2026-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Body Composition
  • Feeding; Difficult, Newborn
  • Nutrition Disorder, Infant