iKanEat: protocol for a randomized controlled trial of megestrol as a component of a pediatric tube weaning protocol
Abstract 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...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2021-02-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-021-05131-w |
| _version_ | 1818914797921501184 |
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| author | Sarah Edwards Paul E. Hyman Hayat Mousa Amanda Bruce Jose Cocjin Kelsey Dean Kandace Fleming Rebecca Swinburne Romine Ann M. Davis |
| author_facet | Sarah Edwards Paul E. Hyman Hayat Mousa Amanda Bruce Jose Cocjin Kelsey Dean Kandace Fleming Rebecca Swinburne Romine Ann M. Davis |
| author_sort | Sarah Edwards |
| collection | DOAJ |
| description | Abstract 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. Trial registration ClinicalTrials.gov NCT#03815019 . Registered on January 17, 2019 |
| first_indexed | 2024-12-19T23:52:06Z |
| format | Article |
| id | doaj.art-30c1ad077eb447a8ac005cb8bd554b2c |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-19T23:52:06Z |
| publishDate | 2021-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-30c1ad077eb447a8ac005cb8bd554b2c2022-12-21T20:01:06ZengBMCTrials1745-62152021-02-0122111210.1186/s13063-021-05131-wiKanEat: protocol for a randomized controlled trial of megestrol as a component of a pediatric tube weaning protocolSarah Edwards0Paul E. Hyman1Hayat Mousa2Amanda Bruce3Jose Cocjin4Kelsey Dean5Kandace Fleming6Rebecca Swinburne Romine7Ann M. Davis8Pediatric Gastroenterology, Children’s Mercy Kansas CityPediatric Gastroenterology, New Orleans Children’s HospitalPediatric Gastroenterology, Hepatology and Nutrition, University of California San Diego/Rady Children’s HospitalDepartment of Pediatrics, University of Kansas Medical CenterPediatric Gastroenterology, Children’s Mercy Kansas CityDepartment of Pediatrics, University of Kansas Medical CenterLife Span Institute, University of KansasLife Span Institute, University of KansasDepartment of Pediatrics, University of Kansas Medical CenterAbstract 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. Trial registration ClinicalTrials.gov NCT#03815019 . Registered on January 17, 2019https://doi.org/10.1186/s13063-021-05131-wTube feedingTube weaningMegestrolFeeding problemsRandomized controlled trial |
| spellingShingle | Sarah Edwards Paul E. Hyman Hayat Mousa Amanda Bruce Jose Cocjin Kelsey Dean Kandace Fleming Rebecca Swinburne Romine Ann M. Davis iKanEat: protocol for a randomized controlled trial of megestrol as a component of a pediatric tube weaning protocol Trials Tube feeding Tube weaning Megestrol Feeding problems Randomized controlled trial |
| title | iKanEat: protocol for a randomized controlled trial of megestrol as a component of a pediatric tube weaning protocol |
| title_full | iKanEat: protocol for a randomized controlled trial of megestrol as a component of a pediatric tube weaning protocol |
| title_fullStr | iKanEat: protocol for a randomized controlled trial of megestrol as a component of a pediatric tube weaning protocol |
| title_full_unstemmed | iKanEat: protocol for a randomized controlled trial of megestrol as a component of a pediatric tube weaning protocol |
| title_short | iKanEat: protocol for a randomized controlled trial of megestrol as a component of a pediatric tube weaning protocol |
| title_sort | ikaneat protocol for a randomized controlled trial of megestrol as a component of a pediatric tube weaning protocol |
| topic | Tube feeding Tube weaning Megestrol Feeding problems Randomized controlled trial |
| url | https://doi.org/10.1186/s13063-021-05131-w |
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