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

Body Composition Clinical Trial

Official title:

Pilot Randomized Controlled Trial Comparing FFM-indexed Feeding vs. Standard Feeding in LGA Infants With Oral Feeding Difficulty and Disproportionate Body Composition.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04599010
• Other study ID #: 871760
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: Nemours Children's Clinic
• Contact: Sreekanth K Viswanathan, MD,MS
• Phone: 4076977603
• Email: sreekanth.viswanathan[@]nemours.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Week to 10 Weeks

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

Related Conditions & MeSH terms

• Body Composition
• Feeding; Difficult, Newborn
• Infant Nutrition Disorders
• Nutrition Disorder, Infant
• Nutrition Disorders

Intervention

Other:
• Dietary intervention
energy-restricted diet appropriate for resting metabolic rate using FFM as proxy

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Nemours Children's Hospital	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Nemours Children's Clinic	Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from study entry to independent oral feeding	full oral feeding defined as 120 ml/kg/d without tube feeding for 2 consecutive days	Before or at NICU-discharge
Secondary	oral feeding volume at NICU discharge	oral feeding volume (mL/kg/day) at discharge	before 3 months
Secondary	NICU Feeding related length of stay (LOS)	Days from first oral feeding to independent oral feeding	before 3 months
Secondary	Gastrostomy rates	Percentage of infants with gastrostomy placement	through study completion, an average of 1 year
Secondary	ARH levels	Directional changes in ARH pre-post intervention	2 weeks
Secondary	Oral feeding success rate	Independent oral feeding at NICU discharge	Before 3 months
Secondary	Body composition change in FM and FFM	Directional changes in FM and FFM pre-post intervention	2 weeks