iKanEat

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The purpose of this study is to help children who are tube-fed transition to eating orally. The goal is to evaluate the effectiveness of treatment with an experimental drug (megestrol) as part of a 24-week behavioral feeding protocol in transitioning from tube to oral feedings in a pediatric population. All children will receive feeding skills coaching to help them learn to eat by mouth, and children will follow a tube weaning protocol to transition from tube to oral feeds. More information can be found at www.ikaneat.org.

ClinicalTrials.gov Identifier

NCT03815019

View full trial information on ClinicalTrials.gov

Eligibility & Criteria

IRB #:
20-017800
Official Title:
iKanEat: A Randomized-Controlled, Multicenter Trial Of Megestrol For Chronic Oral Food Refusal in Children 9 Months to 9 Years 0 Months of Age
Study Phase:
Phase IV
Eligible Age Range:
9 Months - 9 Years
Gender:
All
Study Categories:

Visit Criteria

The study involves 4 visits to a clinic, and 12 tele-visits over phone or video call. Parents/guardians will be asked to complete questionnaires and a diet record before the clinic visits. Parents/guardians will also collect 3 stool samples from their children over the course of the study.

Leader
Hayat Mousa

Hayat Mousa, MD