Recruiting

Observational Study

Sponsor:

Nemours Children's Clinic

Code:

NCT04599010

Conditions

Body Composition

Feeding; Difficult, Newborn

Nutrition Disorder, Infant

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

Dietary intervention

Study Details

Brief 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.

Conditions

Body Composition

Feeding; Difficult, Newborn

Nutrition Disorder, Infant

Study ID

NCT04599010

Start date

Sep 26, 2024

Status verified date

May, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: FFM-indexed feeding

In FFM-indexed feeding, there will be a permissive feeding volume restriction to 150 ± 10 mL/kg (FFM)/day without increasing the milk calorie density or changing the type of formula milk for 2 weeks in the intervention group

active comparator: Standard feeding

The standard feeding approach will include an oral feeding volume goal of 150 ± 10 mL/kg/day during the 2-week study period

Interventions

Dietary intervention

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

Primary outcome measure

  • Time from study entry to independent oral feeding [ Time Frame: Before or at NICU-discharge ]

Central Contacts and Locations

Central contacts

Sreekanth Viswanathan, MD,MS

4076977603sreekanth.viswanathan@nemours.org

Locations

Nemours Children's Hospital

Recruiting

Orlando, Florida, United States, 32827

Contacts

Sreekanth Viswanathan

407-697-7603sreekanth.viswanathan@nemours.org

Emory University

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Kera McNelis, MD

kmmcnel@emory.edu

More Information

Sponsor

Nemours Children's Clinic

Last update posted

May 27, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nemours Children's Clinic on 2026-05-27.