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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Body Composition, Feeding; Difficult, Newborn, Nutrition Disorder, Infant

Intervention / Treatment
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* Other: Dietary intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Week
Maximum Age: 10 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The sample size for this pilot study will be 40 with 20 infants randomized into each arm.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FFM-indexed feeding<br>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 | Other: Dietary intervention<br>* energy-restricted diet appropriate for resting metabolic rate using FFM as proxy<br>|
| Active Comparator: Standard feeding<br>The standard feeding approach will include an oral feeding volume goal of 150 ± 10 mL/kg/day during the 2-week study period | Other: Dietary intervention<br>* energy-restricted diet appropriate for resting metabolic rate using FFM as proxy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from study entry to independent oral feeding | full oral feeding defined as 120 ml/kg/d without tube feeding for 2 consecutive days | Before or at NICU-discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oral feeding volume at NICU discharge | oral feeding volume (mL/kg/day) at discharge | before 3 months | 
| NICU Feeding related length of stay (LOS) | Days from first oral feeding to independent oral feeding | before 3 months | 
| Gastrostomy rates | Percentage of infants with gastrostomy placement | through study completion, an average of 1 year | 
| ARH levels | Directional changes in ARH pre-post intervention | 2 weeks | 
| Oral feeding success rate | Independent oral feeding at NICU discharge | Before 3 months | 
| Body composition change in FM and FFM | Directional changes in FM and FFM pre-post intervention | 2 weeks |