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

NCT ID: NCT04599010

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-26
• Study Completion Date: 2027-02-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

FFM-indexed feeding

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

Group Type: ACTIVE_COMPARATOR

Dietary intervention

Intervention Type: OTHER

energy-restricted diet appropriate for resting metabolic rate using FFM as proxy

Standard feeding

The standard feeding approach will include an oral feeding volume goal of 150 ± 10 mL/kg/day during the 2-week study period

Group Type: ACTIVE_COMPARATOR

Dietary intervention

Intervention Type: OTHER

energy-restricted diet appropriate for resting metabolic rate using FFM as proxy

Interventions

Dietary intervention

energy-restricted diet appropriate for resting metabolic rate using FFM as proxy

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Week
• Maximum Eligible Age: 10 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emory University

OTHER

Sponsor Role: collaborator

Nemours Children's Clinic

OTHER

Sponsor Role: lead

Responsible Party

Sreekanth Viswanathan

Attending Neonatologist, Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sreekanth Viswanathan, MD

Role: PRINCIPAL_INVESTIGATOR

Nemours Children's Clinic

Locations

Nemours Children's Hospital

Orlando, Florida, United States

Site Status: RECRUITING

Emory University

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sreekanth Viswanathan, MD,MS

Role: CONTACT

sreekanth.viswanathan@nemours.org

4076977603

Facility Contacts

Sreekanth Viswanathan

Role: primary

sreekanth.viswanathan@nemours.org

407-697-7603

Kera McNelis, MD

Role: primary

kmmcnel@emory.edu

Other Identifiers

871760

Identifier Type: -

Identifier Source: org_study_id