Clinical trial NCT04599010: Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty
Official title: Pilot Randomized Controlled Trial Comparing FFM-indexed Feeding vs. Standard Feeding in LGA Infants With Oral Feeding Difficulty and Disproportionate Body Composition.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Body Composition
Feeding; Difficult, Newborn
Nutrition Disorder, Infant
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2020-10-22
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The sample size for this pilot study will be 40 with 20 infants randomized into each arm.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time from study entry to independent oral feeding
timeFrame: Before or at NICU-discharge
Secondary outcomes:
measure: oral feeding volume at NICU discharge
timeFrame: before 3 months
measure: NICU Feeding related length of stay (LOS)
timeFrame: before 3 months
measure: Gastrostomy rates
timeFrame: through study completion, an average of 1 year
measure: ARH levels
timeFrame: 2 weeks
measure: Oral feeding success rate
timeFrame: Before 3 months
measure: Body composition change in FM and FFM
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Nemours Children's Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Nemours Children's Clinic
name: Sreekanth Viswanathan, MD
role: PRINCIPAL_INVESTIGATOR
References: