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The safety and efficacy of megesterol as part of an outpatient feeding protocol for children with chronic medical conditions

Award Number: R01HD093933
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Project Summary/Abstract Feeding problems requiring medical intervention occur in 3-10% of children. In addition, severe feeding problems occur in 40-70% of children with chronic medical conditions. Gastrostomy (G-) and gastrojejunal (G- J) tube feeding requirements may persist for months or years resulting in chronic oral food refusal. As the prevalence of gastrostomy tube feeding has increased, so have the challenges associated with managing a child with tube feeding and transitioning a child from tube to oral feeding. Previous research on transitioning children from tube to oral feeding indicates that most programs are inpatient or day treatment, and many children are not successful. Our team developed a novel interdisciplinary outpatient protocol for transitioning children from tube to oral feeding called iKanEat. Data indicate iKanEat is effective for transitioning tube fed children to oral eating. iKanEat results in statistically significant and clinically meaningful increases in oral eating. iKanEat is composed of several key components, including two medications – amitriptyline and megesterol. However, our most recent work (HD066629) suggests that amitriptyline is not a necessary component of the protocol, as all children who completed the protocol consumed 100% of their calories orally at post treatment regardless of receiving amitriptyline or placebo. The current proposal is a randomized controlled trial of the second medication (megesterol) compared to placebo, to determine if megesterol improves the effectiveness of the iKanEat protocol. As all medications have side effects, it is critical we determine if the benefits of megesterol as part of iKanEat outweigh the risks of the medication. The primary aim of the current study is to conduct a randomized controlled trial of megesterol, the only remaining medication that is part of the iKanEat protocol. The second aim is to assess the safety of megesterol as part of the iKanEat protocol. Our previous work (as well as work by others) suggests that a 6 week course of megesterol can lead to adrenal insufficiency in some children, so as part of the current protocol we will assess the safety of a 4 week course of this drug. Finally, parents of tube fed children encounter multiple psychosocial stressors regarding tube feeding. These include concerns about their child’s survival due to their underlying medical issues, feelings of “failure” due to their inability to feed their child orally, increased feelings of stress around the tube feeding, and decreased support from others due to the tube feeding. Our research indicates that quality of life is poor in tube fed children, even more so than children with cancer or burns. Given the significance of these issues, the third aim of the study is to examine the effect of the transition from tube to oral feeding on parent stress and parent and child quality of life.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = $424,405 )
2023	2023	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	3901 RAINBOW BLVD	KANSAS CITY	KS	66160	WYANDOTTE	USA	Child Health and Human Development Extramural Research	000	5	5/31/2023	NON-COMPETING CONTINUATION	$424,405
														Subtotal = $424,405

Issue Date FY: 2022 ( Subtotal = $435,421 )
2022	2022	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	4330 SHAWNEE MISSION PKWY	SHAWNEE MISSION	KS	66205	JOHNSON	USA	Child Health and Human Development Extramural Research	000	4	6/10/2022	NON-COMPETING CONTINUATION	$435,421
														Subtotal = $435,421

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	4330 SHAWNEE MISSION PKWY	SHAWNEE MISSION	KS	66205	JOHNSON	USA	Child Health and Human Development Extramural Research	000	3	6/14/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $435,421 )
2020	2020	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	4330 SHAWNEE MISSION PKWY	SHAWNEE MISSION	KS	66205	JOHNSON	USA	Child Health and Human Development Extramural Research	000	3	6/15/2020	NON-COMPETING CONTINUATION	$435,421
														Subtotal = $435,421

Issue Date FY: 2019 ( Subtotal = $441,224 )
2019	2019	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	4330 SHAWNEE MISSION PKWY	SHAWNEE MISSION	KS	66205	JOHNSON	USA	Child Health and Human Development Extramural Research	001	2	6/5/2019	NON-COMPETING CONTINUATION	$441,224
2019	2018	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	4330 SHAWNEE MISSION PKWY	SHAWNEE MISSION	KS	66205	JOHNSON	USA	Child Health and Human Development Extramural Research	000	1	11/5/2018	NEW	$0
														Subtotal = $441,224

Issue Date FY: 2018 ( Subtotal = $468,963 )
2018	2018	UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE, INC.	4330 SHAWNEE MISSION PKWY	SHAWNEE MISSION	KS	66205	JOHNSON	USA	Child Health and Human Development Extramural Research	000	1	9/13/2018	NEW	$468,963
														Subtotal = $468,963

Grand Total All Awards = $2,205,434

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The safety and efficacy of megesterol as part of an outpatient feeding protocol for children with chronic medical conditions

Award Number: R01HD093933

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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