Sarah Edwards1, Paul E Hyman2, Hayat Mousa3, Amanda Bruce4,5, Jose Cocjin1, Kelsey Dean4,5, Kandace Fleming6, Rebecca Swinburne Romine6, Ann M Davis7,8. 1. Pediatric Gastroenterology, Children's Mercy Kansas City, Kansas City, MO, USA. 2. Pediatric Gastroenterology, New Orleans Children's Hospital, New Orleans, LA, USA. 3. Pediatric Gastroenterology, Hepatology and Nutrition, University of California San Diego/Rady Children's Hospital, San Diego, CA, USA. 4. Department of Pediatrics, University of Kansas Medical Center, 3901 Rainbow Boulevard, MS 4004, Kansas City, KS, 66160, USA. 5. Center for Children's Healthy Lifestyles & Nutrition, Kansas City, MO, USA. 6. Life Span Institute, University of Kansas, Lawrence, KS, USA. 7. Department of Pediatrics, University of Kansas Medical Center, 3901 Rainbow Boulevard, MS 4004, Kansas City, KS, 66160, USA. adavis6@kumc.edu. 8. Center for Children's Healthy Lifestyles & Nutrition, Kansas City, MO, USA. adavis6@kumc.edu.
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.
RCT Entities:
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.
Authors: Sarah Edwards; Ann McGrath Davis; Linda Ernst; Brenda Sitzmann; Amanda Bruce; David Keeler; Osama Almadhoun; Hayat Mousa; Paul Hyman Journal: JPEN J Parenter Enteral Nutr Date: 2015-11 Impact factor: 4.016
Authors: Jeanne M Landgraf; Ineke Vogel; Rianne Oostenbrink; Margriet E van Baar; Hein Raat Journal: Qual Life Res Date: 2012-04-17 Impact factor: 4.147
Authors: Lisa M Orme; Jodie D Bond; Maureen S Humphrey; Margaret R Zacharin; Peter A Downie; Kris M Jamsen; Susan L Mitchell; Jacqueline M Robinson; Natalie A Grapsas; David M Ashley Journal: Cancer Date: 2003-07-15 Impact factor: 6.860
Authors: Ann M Davis; Kelsey Dean; Hayat Mousa; Sarah Edwards; Jose Cocjin; Osama Almadhoun; Jianghua He; Amanda Bruce; Paul E Hyman Journal: J Pediatr Date: 2016-03-03 Impact factor: 4.406
Authors: Geoff D E Cuvelier; Tina J Baker; Elaine F Peddie; Linda M Casey; Pascal J Lambert; Dianne S Distefano; Marlene G Wardle; Beth A Mychajlunow; Marcel A Romanick; David B Dix; Beverly A Wilson Journal: Pediatr Blood Cancer Date: 2013-10-26 Impact factor: 3.167