Phase 4
N=70
iKanEat: A Randomized-controlled, Multi-center Trial of Megestrol for Chronic Oral Food Refusal in Children
Feeding Behavior · Feeding Disorder of Infancy or Early Childhood
Bottom Line
View on ClinicalTrials.gov: NCT03815019 ↗Enrolled (actual)
70
Serious AEs
14.3%
Results posted
Sep 2025
Primary outcome: Primary: Participants Who Transitioned to Oral Feeding — 23; 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Megestrol Acetate (Drug); iKanEat Behavioral Intervention (Behavioral)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Kansas Medical Center
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Who Transitioned to Oral Feeding |
23; 24 | — |
| SECONDARY Number of Participants With Adrenal Insufficiency as Measured by Morning Cortisol Lab Value |
1; 0 | — |
| SECONDARY Change in Child Quality of Life as Measured by the Infant Toddler Quality of Life Scale (ITQOL47) - Global Behavior (GB2) Subscale |
3.4211; 1.4706 | — |
| SECONDARY Change in Child Quality of Life as Measured by the Infant Toddler Quality of Life Scale (ITQOL47) - Combined Behavior Scale (CBE) Subscale |
0.3947; -0.9804 | — |
| SECONDARY Change in Child Quality of Life as Measured by the Child Health Questionnaire Parent Form - CHQ-PF50, 5.1 Behavior (BE) Subscale |
5.0000; 8.3333 | — |
| SECONDARY Change in Child Quality of Life as Measured by the Child Health Questionnaire Parent Form - CHQ-PF50 - 5.2 Global Behavior (GBE) Subscale |
-2.5000; -0.000000000001 | — |
| SECONDARY Change in Parent Stress as Measured by the Pediatric Inventory for Parents (PIP36) - Total Frequency Score |
-20.7500; -21.2500 | — |
| SECONDARY Change in Parent Stress as Measured by the Pediatric Inventory for Parents (PIP36) - Total Difficulty Score |
-18.7143; -21.2083 | — |
| SECONDARY Change in Parent Quality of Life as Measured by the SF-36v2 - Emotional Well-Being Subscale |
0.9655; 3.0000 | — |
| SECONDARY Change in Parent Depressive Symptoms Measured by the Patient Health Questionnaire-9 (PHQ-9) |
-0.5357; 0.4783 | — |
| SECONDARY Change in Parent Anxiety Symptoms Measured by the General Anxiety Disorder-7 (GAD-7). |
-0.9643; -0.7826 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03815019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.