Body Composition, Feeding; Difficult, Newborn, Nutrition Disorder, Infant
Conditions
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.
Interventions
OTHERDietary intervention
energy-restricted diet appropriate for resting metabolic rate using FFM as proxy
Sponsors
Nemours Children's Clinic
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The data analyzer will be masked to the allocation
Intervention model description
The sample size for this pilot study will be 40 with 20 infants randomized into each arm.
Eligibility
Sex/Gender
ALL
Age
1 Weeks to 10 Weeks
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from study entry to independent oral feeding | Before or at NICU-discharge | full oral feeding defined as 120 ml/kg/d without tube feeding for 2 consecutive days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| oral feeding volume at NICU discharge | before 3 months | oral feeding volume (mL/kg/day) at discharge |
| NICU Feeding related length of stay (LOS) | before 3 months | Days from first oral feeding to independent oral feeding |
| Gastrostomy rates | through study completion, an average of 1 year | Percentage of infants with gastrostomy placement |
| ARH levels | 2 weeks | Directional changes in ARH pre-post intervention |
| Oral feeding success rate | Before 3 months | Independent oral feeding at NICU discharge |
| Body composition change in FM and FFM | 2 weeks | Directional changes in FM and FFM pre-post intervention |
Countries
United States
Contacts
CONTACTSreekanth Viswanathan, MD,MS
PRINCIPAL_INVESTIGATORSreekanth Viswanathan, MD
Nemours Children's Clinic
Outcome results
None listed