Megestrol for Feeding Disorders in Children
(iKanEat Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a multi-center, randomized, placebo-controlled, double-blind clinical trial. The primary focus of the study is the evaluation of the effectiveness of treatment with megestrol as part of a 24 week behavioral feeding protocol in transitioning from tube to oral feedings in a pediatric population. Approximately 60 pediatric subjects matching the criteria for eligibility will be enrolled in the study and randomized to receive either megestrol (n=30) or placebo (n=30).
Are You a Good Fit for This Trial?
The iKanEat trial is for children aged 9 months to 9 years with chronic oral food refusal who rely on tube feeding for over 80% of their daily calories. They must have the necessary oral and behavioral skills for eating, as assessed by a multidisciplinary team, and be medically stable to transition from tube to oral feeding.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either megestrol or placebo as part of a 24-week behavioral feeding protocol to transition from tube to oral feedings.
Megestrol Tapering
Megestrol is dosed at full dose weeks 10-11, at 66% dose week 12, at 33% dose week 14, and fully tapered at the end of week 14.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of child quality of life and parent stress.
What Are the Treatments Tested in This Trial?
Interventions
- iKanEat Behavioral Intervention
- Megestrol Acetate
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Kansas Medical Center
Lead Sponsor