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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-10
SponsorNemours Children's Clinic

About this trial

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

Qualifiers

LGA infants with oral feeding difficulty born at ≥ 35 weeks gestation, with FM z-score > +1.0 in body composition measurement

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Dietary intervention

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Nemours Children's Clinic

Lead sponsor

Emory University

Collaborator