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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
energy-restricted diet appropriate for resting metabolic rate using FFM as proxy
Nemours Children's Hospital
Orlando, Florida, United States
RECRUITINGEmory University
Atlanta, Georgia, United States
RECRUITINGTime 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
oral feeding volume at NICU discharge
oral feeding volume (mL/kg/day) at discharge
Time frame: before 3 months
NICU Feeding related length of stay (LOS)
Days from first oral feeding to independent oral feeding
Time frame: before 3 months
Gastrostomy rates
Percentage of infants with gastrostomy placement
Time frame: through study completion, an average of 1 year
ARH levels
Directional changes in ARH pre-post intervention
Time frame: 2 weeks
Oral feeding success rate
Independent oral feeding at NICU discharge
Time frame: Before 3 months
Body composition change in FM and FFM
Directional changes in FM and FFM pre-post intervention
Time frame: 2 weeks
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