Pilot Randomized Controlled Trial Comparing FFM-indexed Feeding vs. Standard Feeding in LGA Infants With Oral Feeding Difficulty and Disproportionate Body Composition.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Nemours Children's Clinic
- Enrollment
- 40
- Locations
- 4
- Primary Endpoint
- Time from study entry to independent oral feeding
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The data analyzer will be masked to the allocation
Eligibility Criteria
- Ages
- 1 Week to 10 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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
Intervention: Dietary intervention (Other)
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
Intervention: Dietary intervention (Other)
Outcomes
Primary Outcomes
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
- oral feeding volume at NICU discharge(before 3 months)
- NICU Feeding related length of stay (LOS)(before 3 months)
- Gastrostomy rates(through study completion, an average of 1 year)
- ARH levels(2 weeks)
- Oral feeding success rate(Before 3 months)
- Body composition change in FM and FFM(2 weeks)
Investigators
Sreekanth Viswanathan
Attending Neonatologist, Professor of Pediatrics
Nemours Children's Clinic