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

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.