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

R
Ryan T. Pitman, MS, MD

Primary Investigator

Enrolling By Invitation
9-108 years
All
Phase 4
60 participants needed
2 Locations

Brief description of study

This is a multi-center, randomized, placebo-controlled, double-blind clinical trial. They focus of the study is the evaluation of the effectiveness of treatment with megestrol24 week behavioral feeding protocol in transitioning from tube to oral feedingsdiatric population. Approximately 60 pediatric subjects matching the criteria forgibility will be enrolled in the study and randomized to receive either megestrol (n=30)bo (n=30).

Detailed description of study

The primary aim of the current study is to conduct a randomized controlled trial of a 4-weekurse of megestrol, the only remaining medication that is part of the iKanEat protocol, toure that the addition of megestrol results in improved child outcomes. The second aim ishe safety of megestrol as part of the iKanEat protocol. Our previous work (as wellwork by others) suggests that a 6 week course of megestrol can lead to adrenalufficiency in some children, so as part of the current protocol, the investigators willhe safety of a 4 week course of this drug.
Finally, parents of tube fed children encounter multiple psychosocial stressors regardingube feeding. These include concerns about their child's survival due to their underlyingdical issues, feelings of "failure" due to their inability to feed their child orally,d feelings of stress around the tube feeding and decreased support from others due tohe tube feeding. Our research indicates that quality of life can be poor in tube fedhildren, even more so than children with cancer or burns. Given the significance of theseues, the third aim of the study is to examine the effect of the transition from tube toding on parent stress and parent and child quality of life.
Aim 1: To assess the efficacy of megestrol as part of the 24 week iKanEat protocol.
Hypothesis 1: Children randomized to the megestrol group will be significantly moreuccessful in making the transition to oral feeding (defined as obtaining at least 90% ofy) than children randomized to the placebo group.
Aim 2: To assess the safety of 4 weeks of megestrol as part of the 24 week iKanEat protocol.
Hypothesis 2A: Children randomized to the megestrol group will not differ from controlhildren in morning cortisol classification level (low, average, high) and will remain withinhe normal range at all time points. Analyses 2B: Exploratory analysis will determine which,y, covariates (gender, age, and diagnoses at week 0, diagnoses at birth) are related tobnormal morning cortisol levels.
Aim 3: To examine the effect of the transition from tube to oral feeding on parent stress andd child quality of life. Hypothesis 3A: The transition to oral feeding willy increase parent stress at week 14 at the cessation of tube feeding, with a returnbaseline by week 24. Hypothesis 3B: The transition to oral feeding will increase/child quality of life at 24 weeks compared to week 0. Children with feeding tubes havew options for treatment other than extensive inpatient stays and expensive day treatmentgrams. iKanEat offers an outpatient, less intensive, empirically supported effectivehat can improve the lives of children and families. It is imperative thathe investigators determine the efficacy and safety of the protocol including 4 weeks ofgestrol before the investigators move toward broad dissemination of the iKanEat protocol.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Feeding Behavior, Feeding Disorder of Infancy or Early Childhood, Riley
  • Age: Between 9 Months - 108 Months
  • Gender: All

Inclusion Criteria:
  1. Males and females aged 9 months to 9y0m at the time of consent.
  2. Able to obtain parental or legal guardian written informed consent from subjects asble by local laws and regulations.
  3. Subjects must have a G or G/J tube.
  4. Subjects must receive over 80% of their total daily calorie needs from a tube in orderbe classified as tube dependent.
  5. Subjects must have a ≥ 3 month history of feeding problems as identified by adiagnosis from a multidisciplinary feeding team, and must have permission from thehysician on the team to ensure that they are medically stable enough to participateweaning study.
  6. Subjects must possess the oral motor skills necessary for eating. Subjects mustbehavioral skills necessary for mealtimes.
Exclusion Criteria:
  1. Children receiving oral or inhaled steroids.
  2. Parent has a known developmental delay or cognitive impairment that may makehe study difficult (children with these issues will not beuded).
  3. Children receiving intensive (defined as more than one session per month) behavioralding therapy with a licensed psychologist (previous behavioral feeding therapy isusion criterion; neither is current oral-motor, sensory, or speechherapy).
  4. Children of non-English speaking parents.

Updated on 13 Sep 2024. Study ID: 2004281940, PGI-KUMC-IKANEAT
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