Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulties
Study Details
Study Description
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 resting metabolic rate (RMR)-matched feeding on the oral intake volumes in LGA infants with oral feeding difficulties.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
Eligible subjects will be randomized to an innovative RMR-matched feeding or the standard feeding for up to 2 weeks. The essential component of the RMR-matched 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 RMR-matched 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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: RMR-matched feeding In RMR-matched 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. |
Other: Dietary intervention
energy-restricted diet
|
| 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 |
Other: Dietary intervention
energy-restricted diet
|
Outcome Measures
Primary Outcome Measures
- Days to oral feeding success [Before NICU-discharge]
days from study entry to 'oral feeding success' defined as independent oral feeding for two consecutive days
Secondary Outcome Measures
- oral feeding volume at discharge [at NICU discharge]
oral feeding volume (mL/kg/day) at discharge
- NICU Feeding related length of stay (LOS) [Before NICU discharge]
Days from first oral feeding to independent oral feeding
- Gastrostomy rates [through study completion, an average of 2 year]
Percentage of infants with gastrostomy placement
- ARH levels [2 weeks]
Directional changes in ARH pre-post intervention
Eligibility Criteria
Criteria
Inclusion Criteria:
- LGA infants with oral feeding difficulties born at ≥ 37 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nemours Children's Hospital | Orlando | Florida | United States | 32827 |
| 2 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
Sponsors and Collaborators
- Nemours Children's Clinic
- Children's Hospital Medical Center, Cincinnati
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 871760