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

被引:1
|
作者
Edwards, Sarah [1 ]
Hyman, Paul E. [2 ]
Mousa, Hayat [3 ]
Bruce, Amanda [4 ,5 ]
Cocjin, Jose [1 ]
Dean, Kelsey [4 ,5 ]
Fleming, Kandace [6 ]
Romine, Rebecca Swinburne [6 ]
Davis, Ann M. [4 ,5 ]
机构
[1] Childrens Mercy Kansas City, Pediat Gastroenterol, Kansas City, MO USA
[2] New Orleans Childrens Hosp, Pediat Gastroenterol, New Orleans, LA USA
[3] Univ Calif San Diego, Rady Childrens Hosp, Pediat Gastroenterol Hepatol & Nutr, San Diego, CA 92103 USA
[4] Univ Kansas, Dept Pediat, Med Ctr, 3901 Rainbow Blvd,MS 4004, Kansas City, KS 66160 USA
[5] Ctr Childrens Hlth Lifestyles & Nutr, Kansas City, MO 64108 USA
[6] Univ Kansas, Life Span Inst, Lawrence, KS 66045 USA
基金
美国国家卫生研究院;
关键词
Tube feeding; Tube weaning; Megestrol; Feeding problems; Randomized controlled trial;
D O I
10.1186/s13063-021-05131-w
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
BackgroundAlthough 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.MethodsThe 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.DiscussionThis 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.Trial registrationClinicalTrials.gov NCT#03815019. Registered on January 17, 2019
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页数:12
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