Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty

Not Applicable

Recruiting

Conditions: Body Composition
Feeding; Difficult, Newborn
Nutrition Disorder, Infant

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
FFM-indexed feeding	Dietary intervention	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 for 2 weeks in the intervention group
Standard feeding	Dietary intervention	The standard feeding approach will include an oral feeding volume goal of 150 ± 10 mL/kg/day during the 2-week study period

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Locations (2): Nemours Children's Hospital
🇺🇸
Orlando, Florida, United States
Emory University
🇺🇸
Atlanta, Georgia, United States