CompletedPhase 4

iKanEat: A Randomized-controlled, Multi-center Trial of Megestrol for Chronic Oral Food Refusal in Children

United States70 participantsStarted 2019-08-15

Plain-language 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 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).

Who can participate

Age range9 Months – 108 Months

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Participants Who Transitioned to Oral Feeding

Timeframe: Weeks 0 to 24

Trial details

NCT IDNCT03815019

SponsorUniversity of Kansas Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-19

Results submitted2025-07-22

View on ClinicalTrials.gov More Feeding Behavior trials