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Dietary Intervention

Dietary Intervention for Feeding Difficulties in Large Infants

N/A
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time from study entry to independent oral feeding
Secondary outcome measures
ARH levels
Body composition change in FM and FFM
Gastrostomy rates
+3 more

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

Find a Location

Who is running the clinical trial?

Nemours Children's ClinicLead Sponsor
125 Previous Clinical Trials
18,127 Total Patients Enrolled
Children's Hospital Medical Center, CincinnatiOTHER
815 Previous Clinical Trials
6,530,630 Total Patients Enrolled

Media Library

Dietary intervention (Dietary Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04599010 — N/A
Nutrition Disorder Research Study Groups: FFM-indexed feeding, Standard feeding
Nutrition Disorder Clinical Trial 2023: Dietary intervention Highlights & Side Effects. Trial Name: NCT04599010 — N/A
Dietary intervention (Dietary Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04599010 — N/A
~27 spots leftby May 2026
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