Dietary Intervention
Otherenergy-restricted diet appropriate for resting metabolic rate using FFM as proxy
NCT Number: NCT04599010
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.
Interested in participating?
Request Info1 week–10 week
All sexes
Interventional
Not applicable
Nemours Children's Hospital, Orlando, Florida, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
energy-restricted diet appropriate for resting metabolic rate using FFM as proxy
Time frame: Before or at NICU-discharge
full oral feeding defined as 120 ml/kg/d without tube feeding for 2 consecutive days
Time frame: before 3 months
oral feeding volume (mL/kg/day) at discharge
Time frame: before 3 months
Days from first oral feeding to independent oral feeding
Time frame: through study completion, an average of 1 year
Percentage of infants with gastrostomy placement
Time frame: 2 weeks
Directional changes in ARH pre-post intervention
Time frame: Before 3 months
Independent oral feeding at NICU discharge
Time frame: 2 weeks
Directional changes in FM and FFM pre-post intervention
Contact information is provided by the study sponsor or research team.
Nemours Children's Clinic
Other
Pilot Randomized Controlled Trial Comparing FFM-indexed Feeding vs. Standard Feeding in LGA Infants With Oral Feeding Difficulty and Disproportionate Body Composition.
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