Status:
COMPLETED
iKanEat: A Randomized-controlled, Multi-center Trial of Megestrol for Chronic Oral Food Refusal in Children
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Feeding Behavior
Feeding Disorder of Infancy or Early Childhood
Eligibility:
All Genders
9-108 years
Phase:
PHASE4
Brief Summary
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 w...
Detailed Description
The primary aim of the current study is to conduct a randomized controlled trial of a 4-week course of megestrol, the only remaining medication that is part of the iKanEat protocol, to ensure that the...
Eligibility Criteria
Inclusion
- Males and females aged 9 months to 9y0m at the time of consent.
- Able to obtain parental or legal guardian written informed consent from subjects as applicable by local laws and regulations.
- Subjects must have a G or G/J tube.
- Subjects must receive over 80% of their total daily calorie needs from a tube in order to be classified as tube dependent.
- Subjects must have a ≥ 3 month history of feeding problems as identified by a diagnosis from a multidisciplinary feeding team, and must have permission from the physician on the team to ensure that they are medically stable enough to participate in a weaning study.
- Subjects must possess the oral motor skills necessary for eating. Subjects must possess behavioral skills necessary for mealtimes.
Exclusion
- Children receiving oral or inhaled steroids.
- Parent has a known developmental delay or cognitive impairment that may make participation in the study difficult (children with these issues will not be excluded).
- Children receiving intensive (defined as more than one session per month) behavioral feeding therapy with a licensed psychologist (previous behavioral feeding therapy is not an exclusion criterion; neither is current oral-motor, sensory, or speech therapy).
- Children of non-English speaking parents.
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03815019
Start Date
August 15 2019
End Date
March 19 2025
Last Update
September 10 2025
Active Locations (8)
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1
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
2
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
3
Riley Hospital for Children at IU Health
Indianapolis, Indiana, United States, 46202
4
Boston Children's Hospital
Boston, Massachusetts, United States, 02115