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IMPACT OF TREATMENT OF MILD SLEEP-DISORDERED BREATHING ON CHILDREN'S HEALTH-CCC

Award Number: U01HL125295
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/04/2015
PERIOD OF PERFORMANCE END DATE: 06/30/2022

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IMPACT OF TREATMENT OF MILD SLEEP-DISORDERED BREATHING ON CHILDREN'S HEALTH-CCC - DESCRIPTION (provided by applicant): Adenotonsillectomy (AT) is one of the most common surgical procedures performed in children, with more than 500,000 operations performed annually in the US. A large proportion of these are performed in children with primary snoring, or mild sleep-disordered breathing (MSDB) rather than in children with frank obstructive sleep apnea. Although AT has been shown to improve behavior and quality of life in school-aged children with sleep apnea, the role of this common surgery in children with MSDB is not known, resulting in large practice and geographic variation in its use. Considering the morbidity and health care costs of AT, it is crucial to determine the impact of the surgery on outcomes of value to patients and the healthcare system. We propose to take advantage of a successful collaboration of leaders in sleep medicine, otolaryngology, neuropsychology and clinical trials to conduct a randomized clinical trial of AT for MSDB. The overall hypothesis of this proposal is that children with MSDB benefit from AT as defined by improved behaviour and attention (primary outcomes) and decreased health care utilization. Using a single-blinded, randomized design, we aim to recruit 460 children (50% minority), aged 3-9 years, with polysomnographically-confirmed MSDB from 5 leading pediatric centers. Participants will be randomized to early AT or watchful waiting with supportive care, and undergo standardized evaluations of sleep, behavior, attention, quality of life, and health care utilization at baseline and 12 months. Body habitus, urinary cotinine levels, actigraphy, family functioning, atopy and socioeconomic status will be assessed to identify potential moderating influences. This rigorous design and comprehensive study will resolve existing uncertainties on initial management approaches for pediatric MSDB by addressing several critical issues: a) assess outcomes of importance to children and their families, particularly the patient- reported outcomes of behavior, quality of life, and sleep disturbances); b) examine differences in treatment responses among children who are at increased risk for MSDB, such as pre-school children, minorities, and children with asthma or obesity; c) evaluate health care utilization as a unique and timely outcome; d) assess moderating influences of second hand smoke, insufficient sleep, socioeconomic status and family functioning. Study results will provide evidence on whether children with MSDB benefit from surgery and will identify subgroups who are most likely to benefit, thus informing future management approaches of this common pediatric condition and helping to direct resources to those children most likely to benefit.


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 = -$15,238 )
2023	2019	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	000	5	7/19/2023	NON-COMPETING CONTINUATION	-$15,238
														Subtotal = -$15,238

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2019	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	000	5	11/30/2021	NON-COMPETING CONTINUATION	$0
2022	2019	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	001	5	2/4/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	003	5	6/25/2020	NON-COMPETING CONTINUATION	$0
2020	2019	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	002	5	3/20/2020	NON-COMPETING CONTINUATION	$0
2020	2019	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	000	5	11/8/2019	NON-COMPETING CONTINUATION	$0
2020	2019	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	001	5	2/8/2020	NON-COMPETING CONTINUATION	$0
2020	2019	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	004	5	8/3/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $1,093,842 )
2019	2019	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	001	5	7/29/2019	NON-COMPETING CONTINUATION	$1,093,842
2019	2018	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	000	4	6/25/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,093,842

Issue Date FY: 2018 ( Subtotal = $2,279,250 )
2018	2018	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	001	4	9/2/2018	NON-COMPETING CONTINUATION	$0
2018	2018	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	000	4	7/20/2018	NON-COMPETING CONTINUATION	$1,459,025
2018	2018	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	002	4	9/14/2018	SUPPLEMENT FOR EXPANSION	$820,225
														Subtotal = $2,279,250

Issue Date FY: 2017 ( Subtotal = $1,505,551 )
2017	2017	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	000	3	7/22/2017	NON-COMPETING CONTINUATION	$1,505,551
														Subtotal = $1,505,551

Issue Date FY: 2016 ( Subtotal = $1,539,103 )
2016	2016	CHILDREN'S HOSPITAL OF PHILADELPHIA	34TH ST & CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Lung Diseases Research	001	2	8/8/2016	NON-COMPETING CONTINUATION	$1,528,384
2016	2015	CHILDREN'S HOSPITAL OF PHILADELPHIA	34TH ST & CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Cardiovascular Diseases Research	000	1	11/25/2015	NEW	$10,719
														Subtotal = $1,539,103

Issue Date FY: 2015 ( Subtotal = $1,522,244 )
2015	2015	CHILDREN'S HOSPITAL OF PHILADELPHIA	34TH ST & CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Cardiovascular Diseases Research	000	1	9/4/2015	NEW	$1,522,244
2015	2015	CHILDREN'S HOSPITAL OF PHILADELPHIA	34TH ST & CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Cardiovascular Diseases Research	001	1	9/16/2015	NEW	$0
														Subtotal = $1,522,244

Grand Total All Awards = $7,924,752

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IMPACT OF TREATMENT OF MILD SLEEP-DISORDERED BREATHING ON CHILDREN'S HEALTH-CCC

Award Number: U01HL125295

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/04/2015

PERIOD OF PERFORMANCE END DATE: 06/30/2022

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