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Clinical and Social Implications of 2-Day Genome Results in Acutely III Newborns

Award Number: U19HD077693
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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DESCRIPTION (provided by applicant): Large scale studies of whole genome sequencing (WGS) in neonates have largely been neglected. Thus, its clinical and social implications are largely unknown. The proposed study aims to increase scientific knowledge of these implications for acutely ill neonates. This population may stand to benefit largely from WGS given the severity of illness. The proposed clinical study is a prospective, randomized, partially blinded study which has both quantitative and qualitative assessments of the risks and benefits of the use of STATseq, a 2-day genome test, in acutely ill neonates at Children's Mercy Hospital. Study participants include neonates, their parents and clinicians caring for them. The overall aims will provide a nuanced understanding of the role of rapid diagnostic WGS for acutely ill neonates, including relative diagnostic sensitivity and change in management both for broad NICU populations and subpopulations, accuracy, reproducibility, and relative value of proband WGS and familial triads. The technologic aims include improving diagnostic sensitivity without sacrificing the rapid turnaround time. The clinical aims include looking at increased diagnostic yield, shorter time to diagnosis and clinician perception of management changes that result from implementation of STAT-seq. Finally, the study will investigate the perceived value of STAT-seq in parents and clinicians using structural equation modeling. The studies also are designed for long term continuation of assessment of the enrollees (beyond the current funding period) and in additional sample types (via a bio repository). Long term continuation studies will test effects on long term morbidity, mortality, quality of life and cost of care. We hope that the study results will be sufficient to provide an evidence base for physician adoption and provider reimbursement of WGS in Level 3 and 4 NICUs.


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 = -$1,344,585 )
2023	2018	RADY CHILDREN'S HOSPITAL RESEARCH CENTER	3020 CHILDRENS WAY # 5129	SAN DIEGO	CA	92123	SAN DIEGO	USA	Child Health and Human Development Extramural Research	001	6	10/1/2022	SUPPLEMENT FOR EXPANSION	-$589,566
2023	2018	RADY CHILDREN'S HOSPITAL RESEARCH CENTER	3020 CHILDRENS WAY # 5129	SAN DIEGO	CA	92123	SAN DIEGO	USA	Child Health and Human Development Extramural Research	003	6	3/22/2023	SUPPLEMENT FOR EXPANSION	-$50,001
2023	2018	RADY CHILDREN'S HOSPITAL RESEARCH CENTER	3020 CHILDRENS WAY # 5129	SAN DIEGO	CA	92123	SAN DIEGO	USA	Child Health and Human Development Extramural Research	002	6	3/22/2023	SUPPLEMENT FOR EXPANSION	-$44,584
2023	2018	RADY CHILDREN'S HOSPITAL RESEARCH CENTER	3020 CHILDRENS WAY # 5129	SAN DIEGO	CA	92123	SAN DIEGO	USA	Child Health and Human Development Extramural Research	000	6	10/1/2022	SUPPLEMENT FOR EXPANSION	-$660,434
														Subtotal = -$1,344,585

Issue Date FY: 2021 ( Subtotal = -$5,415 )
2021	2018	RADY CHILDREN'S HOSPITAL RESEARCH CENTER	3020 CHILDRENS WAY # 5129	SAN DIEGO	CA	92123	SAN DIEGO	USA	Child Health and Human Development Extramural Research	000	6	9/7/2021	SUPPLEMENT FOR EXPANSION	-$5,415
														Subtotal = -$5,415

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2017	RADY CHILDREN'S HOSPITAL RESEARCH CENTER	3020 CHILDRENS WAY # 5129	SAN DIEGO	CA	92123	SAN DIEGO	USA	Child Health and Human Development Extramural Research	002	6	4/22/2019	NON-COMPETING CONTINUATION	-$1,250,000
2019	2017	RADY CHILDREN'S HOSPITAL RESEARCH CENTER	3020 CHILDRENS WAY # 5129	SAN DIEGO	CA	92123	SAN DIEGO	USA	Child Health and Human Development Extramural Research	003	6	4/25/2019	NON-COMPETING CONTINUATION	$1,250,000
2019	2016	RADY CHILDREN'S HOSPITAL RESEARCH CENTER	3020 CHILDRENS WAY # 5129	SAN DIEGO	CA	92123	SAN DIEGO	USA	Child Health and Human Development Extramural Research	000	5	4/18/2019	NON-COMPETING CONTINUATION	-$1,237,500
2019	2016	RADY CHILDREN'S HOSPITAL RESEARCH CENTER	3020 CHILDRENS WAY # 5129	SAN DIEGO	CA	92123	SAN DIEGO	USA	Child Health and Human Development Extramural Research	001	5	4/19/2019	NON-COMPETING CONTINUATION	$1,237,500
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $100,000 )
2018	2018	RADY CHILDREN'S HOSPITAL RESEARCH CENTER	7920 FROST ST STE 300	SAN DIEGO	CA	92123	SAN DIEGO	USA	Child Health and Human Development Extramural Research	005	6	9/13/2018	SUPPLEMENT FOR EXPANSION	$100,000
2018	2017	RADY CHILDREN'S HOSPITAL RESEARCH CENTER	7920 FROST ST STE 300	SAN DIEGO	CA	92123	SAN DIEGO	USA	Child Health and Human Development Extramural Research	004	6	9/6/2018	NON-COMPETING CONTINUATION	$0
2018	2016	RADY CHILDREN'S HOSPITAL RESEARCH CENTER	7920 FROST ST STE 300	SAN DIEGO	CA	92123	SAN DIEGO	USA	Child Health and Human Development Extramural Research	003	5	1/29/2018	NON-COMPETING CONTINUATION	-$250,398
2018	2016	RADY CHILDREN'S HOSPITAL RESEARCH CENTER	7920 FROST ST STE 300	SAN DIEGO	CA	92123	SAN DIEGO	USA	Child Health and Human Development Extramural Research	001	5	1/9/2018	NON-COMPETING CONTINUATION	$250,398
2018	2015	RADY CHILDREN'S HOSPITAL RESEARCH CENTER	7920 FROST ST STE 300	SAN DIEGO	CA	92123	SAN DIEGO	USA	Child Health and Human Development Extramural Research	002	4	1/29/2018	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$250,398
2018	2015	RADY CHILDREN'S HOSPITAL RESEARCH CENTER	7920 FROST ST STE 300	SAN DIEGO	CA	92123	SAN DIEGO	USA	Child Health and Human Development Extramural Research	000	4	1/9/2018	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$250,398
														Subtotal = $100,000

Issue Date FY: 2017 ( Subtotal = $1,250,000 )
2017	2017	RADY CHILDREN'S HOSPITAL RESEARCH CENTER	3020 CHILDRENS WAY	SAN DIEGO	CA	92123	SAN DIEGO	USA	Child Health and Human Development Extramural Research	000	6	9/8/2017	NON-COMPETING CONTINUATION	$1,250,000
														Subtotal = $1,250,000

Issue Date FY: 2016 ( Subtotal = $1,382,573 )
2016	2016	CHILDRENS HOSPITAL RESEARCH CENTER	3020 CHILDRENS WAY, MC 5001	SAN DIEGO	CA	92123	SAN DIEGO	USA	Child Health and Human Development Extramural Research	007	5	9/19/2016	NON-COMPETING CONTINUATION	$0
2016	2016	CHILDRENS HOSPITAL RESEARCH CENTER	3020 CHILDRENS WAY, MC 5001	SAN DIEGO	CA	92123	SAN DIEGO	USA	Child Health and Human Development Extramural Research	006	5	9/13/2016	NON-COMPETING CONTINUATION	$1,237,500
2016	2016	CHILDRENS HOSPITAL RESEARCH CENTER	3020 CHILDRENS WAY, MC 5001	SAN DIEGO	CA	92123	SAN DIEGO	USA	Child Health and Human Development Extramural Research	004	4	4/7/2016	SUPPLEMENT FOR EXPANSION	$31,800
2016	2015	CHILDRENS HOSPITAL RESEARCH CENTER	3020 CHILDRENS WAY, MC 5001	SAN DIEGO	CA	92123	SAN DIEGO	USA	Child Health and Human Development Extramural Research	003	4	3/16/2016	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,136,727
2016	2015	CHILDRENS HOSPITAL RESEARCH CENTER	3020 CHILDRENS WAY, MC 5001	SAN DIEGO	CA	92123	SAN DIEGO	USA	Child Health and Human Development Extramural Research	005	4	9/9/2016	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$113,273
2016	2015	CHILDREN'S MERCY HOSPITAL	2401 GILLHAM ROAD	KANSAS CITY	MO	64108	JACKSON	USA	Child Health and Human Development Extramural Research	000	3	1/22/2016	NON-COMPETING CONTINUATION	-$1,136,727
2016	2015	CHILDRENS HOSPITAL RESEARCH CENTER	3020 CHILDRENS WAY, MC 5001	SAN DIEGO	CA	92123	SAN DIEGO	USA	Child Health and Human Development Extramural Research	002	4	2/4/2016	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$1,136,727
2016	2015	CHILDRENS HOSPITAL RESEARCH CENTER	3020 CHILDRENS WAY, MC 5001	SAN DIEGO	CA	92123	SAN DIEGO	USA	Child Health and Human Development Extramural Research	001	4	1/22/2016	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,136,727
														Subtotal = $1,382,573

Issue Date FY: 2015 ( Subtotal = $1,136,727 )
2015	2015	CHILDREN'S MERCY HOSPITAL	2401 GILLHAM ROAD	KANSAS CITY	MO	64108	JACKSON	USA	Child Health and Human Development Extramural Research	000	3	8/21/2015	NON-COMPETING CONTINUATION	$1,136,727
														Subtotal = $1,136,727

Issue Date FY: 2014 ( Subtotal = $1,141,278 )
2014	2014	CHILDREN'S MERCY HOSPITAL	2401 GILLHAM ROAD	KANSAS CITY	MO	64108	JACKSON	USA	Child Health and Human Development Extramural Research	000	2	8/28/2014	NON-COMPETING CONTINUATION	$1,141,278
														Subtotal = $1,141,278

Issue Date FY: 2013 ( Subtotal = $1,183,128 )
2013	2013	CHILDREN'S MERCY HOSPITAL	2401 GILLHAM ROAD	KANSAS CITY	MO	64108	JACKSON	USA	Child Health and Human Development Extramural Research	000	1	9/3/2013	NEW	$1,183,128
														Subtotal = $1,183,128

Grand Total All Awards = $4,843,706

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Clinical and Social Implications of 2-Day Genome Results in Acutely III Newborns

Award Number: U19HD077693

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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