RecruitingNot ApplicableNCT04599010

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

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


Sponsor

Nemours Children's Clinic

Enrollment

40 participants

Start Date

Sep 26, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 WeekMax Age: 10 Weeks

Inclusion Criteria1

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

Exclusion Criteria1

  • 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

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Interventions

OTHERDietary intervention

energy-restricted diet appropriate for resting metabolic rate using FFM as proxy


Locations(2)

Nemours Children's Hospital

Orlando, Florida, United States

Emory University

Atlanta, Georgia, United States

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NCT04599010


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