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NCT Number: NCT04599010

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

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.

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Key information

Age range

1 week–10 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nemours Children's Hospital, Orlando, Florida, United States

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About this study

Eligible subjects will be randomized to an innovative FFM-indexed feeding or the standard feeding for up to 2 weeks. The essential component of the FFM-indexed feeding will be the difference in milk prescription dosing that we propose to set the feeding volume to index FFM rather than total mass. 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, whereas the standard feeding will include a feeding volume goal of 150 ± 10 mL/kg (body weight)/day. Infants will receive either breast milk or formula feedings per the standard feeding protocols. Body composition (PEAPOD system) and appetite-regulating hormones (ARH) levels of enrolled infants will be assessed at baseline (test-1) and at the end 2-week study intervention period (test-2). Subjects will be followed for clinical and growth outcomes until neonatal intensive care unit (NICU) discharge and through 6 months of age. Growth will be followed through 6 months of age by retrieving anthropometric measurement records from pediatricians at well-child visits (2-, 4-, 6- and 6-month visits). Parents will be called at these time points to obtain a history of any further feeding difficulties.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Intervention

Other

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

Primary outcomes

  1. Time from study entry to independent oral feeding

    Time frame: Before or at NICU-discharge

    full oral feeding defined as 120 ml/kg/d without tube feeding for 2 consecutive days

Secondary outcomes

  1. oral feeding volume at NICU discharge

    Time frame: before 3 months

    oral feeding volume (mL/kg/day) at discharge

  2. NICU Feeding related length of stay (LOS)

    Time frame: before 3 months

    Days from first oral feeding to independent oral feeding

  3. Gastrostomy rates

    Time frame: through study completion, an average of 1 year

    Percentage of infants with gastrostomy placement

  4. ARH levels

    Time frame: 2 weeks

    Directional changes in ARH pre-post intervention

  5. Oral feeding success rate

    Time frame: Before 3 months

    Independent oral feeding at NICU discharge

  6. Body composition change in FM and FFM

    Time frame: 2 weeks

    Directional changes in FM and FFM pre-post intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Sreekanth Viswanathan, MD,MS

CONTACT

[email protected]

4076977603

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Collaborators

  • Emory University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 22, 2020
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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