iKanEat: Protocol for a randomized controlled trial of megestrol as a component of a pediatric tube weaning protocol

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Issue Date
2021-02-27Author
Edwards, Sarah
Hyman, Paul E.
Mousa, Hayat
Bruce, Amanda
Cocjin, Jose
Dean, Kelsey
Fleming, Kandace
Romine, Rebecca Swinburne
Davis, Ann M.
Publisher
BMC
Type
Article
Article Version
Scholarly/refereed, publisher version
Rights
© The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License.
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Show full item recordAbstract
Background
Although tube feeding routinely saves the lives of children who do not eat by mouth, chronic tube feeding can be a burden to patients, caregivers, and families. Very few randomized trials exist regarding the best methods for weaning children from their feeding tubes.Methods
The current paper describes a randomized controlled trial of an empirically supported outpatient treatment protocol for moving children from tube to oral eating called iKanEat. Specifically, we describe the methods of randomized double-blind, placebo-controlled trial which includes a 4-week course of megestrol, the only medication used in the iKanEat protocol, to determine whether the addition of megestrol results in improved child outcomes. The primary and secondary aims are to assess the safety and efficacy of megestrol as part of the iKanEat protocol. The third aim is to provide critical information about the impact of the transition from tube to oral feeding on parent stress and parent and child quality of life.Discussion
This trial will provide data regarding whether megestrol is a safe and effective component of the iKanEat tube weaning protocol, as well as important data on how the tube weaning process impacts parent stress and parent and child quality of life.
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Citation
Edwards, S., Hyman, P. E., Mousa, H., Bruce, A., Cocjin, J., Dean, K., Fleming, K., Romine, R. S., & Davis, A. M. (2021). iKanEat: protocol for a randomized controlled trial of megestrol as a component of a pediatric tube weaning protocol. Trials, 22(1), 169. https://doi.org/10.1186/s13063-021-05131-w
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