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

NCT04599010 | Recruiting DMC

• 1 other identifier: 871760
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• oral feeding volume at NICU discharge

  before 3 months

• NICU Feeding related length of stay (LOS)

  before 3 months

• Gastrostomy rates

  through study completion, an average of 1 year

• ARH levels

  2 weeks

• Oral feeding success rate

  Before 3 months

Study Arms (2)

FFM-indexed feeding

ACTIVE COMPARATOR

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

Other: Dietary intervention

Standard feeding

ACTIVE COMPARATOR

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

Other: Dietary intervention

Interventions

Dietary intervention OTHER

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

FFM-indexed feeding; Standard feeding

Eligibility Criteria

• Age: 1 Week - 10 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• LGA infants with oral feeding difficulty born at ≥ 35 weeks gestation, with FM z-score \> +1.0 in body composition measurement

You may not qualify if:

• 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

Sponsors & Collaborators

• Nemours Children's Clinic: lead
• Emory University: collaborator

Study Sites (2)

Nemours Children's Hospital

Orlando, Florida, 32827, United States

RECRUITING

Emory University

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Conditions

Infant Nutrition Disorders

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Sreekanth Viswanathan, MD

  Nemours Children's Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sreekanth Viswanathan, MD,MS

CONTACT

4076977603; sreekanth.viswanathan@nemours.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The data analyzer will be masked to the allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Neonatologist, Professor of Pediatrics

Model Details: The sample size for this pilot study will be 40 with 20 infants randomized into each arm.

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 22, 2020
• Study Start: September 26, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data requests can be submitted starting 9 months after article publication
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)

Locations

US (2)