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

ConditionsBody CompositionFeeding; Difficult, NewbornNutrition Disorder, Infant
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Dietary intervention

    Other intervention

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: FFM-indexed feedingActive comparator 1 intervention
Group B: Standard feedingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time from study entry to independent oral feeding

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

Time frame
Before or at NICU-discharge

Secondary outcomes

1

oral feeding volume at NICU discharge

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

Time frame
before 3 months
2

NICU Feeding related length of stay (LOS)

Days from first oral feeding to independent oral feeding

Time frame
before 3 months
3

Gastrostomy rates

Percentage of infants with gastrostomy placement

Time frame
through study completion, an average of 1 year
4

ARH levels

Directional changes in ARH pre-post intervention

Time frame
2 weeks

Other outcomes

Sponsors and contacts

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Nemours Children's Clinic

Lead sponsor

Emory University

Collaborator

Source ClinicalTrials.gov
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