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Dietary Intervention

Dietary Intervention for Feeding Difficulties in Large Infants

N/A

Recruiting

Led By Sreekanth Viswanathan, MD

Research Sponsored by Nemours Children's Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Must not have

Significant neurological morbidities

Videofluoroscopic swallow study (VFSS) demonstrating unsafe swallowing function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of a short-term, energy-restricted diet on full-term infants who were born large for gestational age and are having difficulty feeding orally.

Who is the study for?

This trial is for large-for-gestational-age (LGA) infants born at or after 35 weeks, who have trouble with oral feeding and a body composition showing excess fat. Infants must not be on respiratory support, have certain swallowing issues, GI surgeries, serious neurological conditions, or major congenital/genetic disorders.

What is being tested?

The study aims to see if adjusting the diet of LGA infants based on their lean body mass rather than fat can help them eat better. It's testing whether this dietary change improves how much they can take in during feedings.

What are the potential side effects?

Since this trial involves dietary changes in infants with feeding difficulties, potential side effects may include digestive discomfort or changes in eating patterns. However, specific side effects are not detailed here.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have serious nerve-related health issues.

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My swallowing test shows I have trouble swallowing safely.

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I have a major genetic condition or birth defect.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time from study entry to independent oral feeding

Secondary study objectives

ARH levels

Body composition change in FM and FFM

Gastrostomy rates

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: FFM-indexed feedingActive Control1 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

Group II: Standard feedingActive Control1 Intervention

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

0 / 3Eligibility criteria met