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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 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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Nemours Children's ClinicLead Sponsor

124 Previous Clinical Trials

18,091 Total Patients Enrolled

Children's Hospital Medical Center, CincinnatiOTHER

815 Previous Clinical Trials

6,531,551 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still ongoing for this scientific trial?

"According to the clinicaltrials.gov portal, this medical trial is no longer recruiting patients. Initially posted on April 1st 2023, it was last updated in October 25th 2022. Despite this inactive research effort, there are presently 114 other trials that need participants right now."

Answered by AI

Am I a suitable candidate to join this research endeavor?

"This research requires a sample of 40 individuals ranging from newborns to 10 weeks old suffering from nutrition disorder. In addition, participants must be large for gestational age (LGA) and have difficulty consuming food orally with body composition measurement z-score higher than +1.0 at birth ≥ 35 weeks gestation."

Answered by AI

Does this research endeavor include individuals older than 20 years of age?

"According to the research requirements, only participants between one week and ten weeks of age are eligible for this trial. There is also a separate 28 trials targeting individuals under 18 years old and another 83 which cater to those above 65."

Answered by AI

What results is this trial designed to produce?

"This research trial aims to track the time from enrollment to achieving independent oral feeding. Supplementary metrics that will be monitored include duration of stay in a Neonatal Intensive Care Unit, total days spent under NICU care before discharge, and any alterations in body composition."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04599010.

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