Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dietary intervention.
- Who it may be relevant to
- Registry conditions: Body Composition, Feeding; Difficult, Newborn, Nutrition Disorder, Infant. Basic parameters: 1 Week — 10 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Randomized Controlled Trial Comparing FFM-indexed Feeding vs. Standard Feeding in LGA Infants With Oral Feeding Difficulty and Disproportionate Body Composition.
Overview
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
- Other Dietary intervention
energy-restricted diet appropriate for resting metabolic rate using FFM as proxy
Primary outcome measures
- Time from study entry to independent oral feeding [Time frame: Before or at NICU-discharge]
Secondary outcome measures (6)
- oral feeding volume at NICU discharge [Time frame: before 3 months]
- NICU Feeding related length of stay (LOS) [Time frame: before 3 months]
- Gastrostomy rates [Time frame: through study completion, an average of 1 year]
- ARH levels [Time frame: 2 weeks]
- Oral feeding success rate [Time frame: Before 3 months]
- Body composition change in FM and FFM [Time frame: 2 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Nemours Children's Hospital — Orlando
- Emory University — Atlanta
Identifiers
NCT: NCT04599010 · 871760