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Neonatal Research Network Data Coordinating Center (DCC) 2023-2028

Award Number: U24HD095254
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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PROJECT SUMMARY/ABSTRACT Critical gaps in neonatal research require multicenter involvement and innovative designs to study them. NICHD views the next chapter of its Neonatal Research Network (NRN) as its “primary and first-line infrastructure” for conducting definitive, rigorous, and reproducible multicenter clinical research in newborns that generates evidence to guide clinical practice. There is a crucial need for an independent Data Coordinating Center (DCC) to provide sophisticated and impartial biostatistical and operational expertise that helps the NRN target its resources and optimize its scientific impact by (1) helping identify research topics of high priority, (2) providing objective statistical expertise for the design and analyses of rigorous and feasible studies, (3) developing processes and systems to increase efficiencies and optimize effective usage of limited resources through external partnerships that amplify the NRN scientific goals, (4) ensuring standardization of study design, development, data collection and analyses, and (5) disseminating results. RTI has been the DCC for the NRN since 1998 and proposes to continue in this role for the next 7 years. We will maximize the scientific impact of the NRN by (1) collaborating in the development of rigorous and innovative trial designs and statistical methods to address the unique challenges in neonatal research; (2) optimizing productivity by providing flexible and efficient data/project management and study monitoring, and promote data sharing, integration, and harmonization; (3) vigorously pursuing external partnerships to support and amplify NRN scientific goals; (4) protecting participant safety and study integrity; (5) providing timely data analysis and collaborative dissemination for all NRN studies; and (6) providing the logistical, communications, and regulatory support necessary to run an efficient and productive multicenter clinical research network. Dr. Abhik Das, the proposed PI, has extensive experience in neonatal clinical studies, leading the NRN DCC for the past 17 years. He will be assisted by Alternate PI, Dr. Carla Bann, and staff with significant NRN experience. This application has unique strengths to help advance the NRN research agenda: (1) a highly qualified and motivated PI and staff with in-depth knowledge and years of experience in neonatal research needs, enabling seamless continuation of NRN research without additional training or resources; (2) proven track record of scientific productivity documented in the quality and quantity of NRN studies and publications supported by RTI that have changed clinical practice, and leveraging the NRN infrastructure to advance NICHD and NRN scientific goals; (3) a state-of-the-art infrastructure of tools, processes, and systems that are flexible and customized to the needs of the NRN; (4) multidisciplinary experts who can collaborate with NRN Investigators to realize research goals; (5) robust data management systems customized for the NRN that ensure data quality; and (6) an agile administrative structure providing maximum flexibility in staffing and contractual operations to respond quickly to changing NRN needs.


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: 2025 ( Subtotal = $0 )
2025	2024	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	000	7	12/12/2024	NON-COMPETING CONTINUATION	$0
2025	2023	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	002	6	1/8/2025	COMPETING CONTINUATION	-$35,153
2025	2021	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	001	4	1/8/2025	NON-COMPETING CONTINUATION	$35,153
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $3,506,271 )
2024	2024	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	005	7	6/6/2024	NON-COMPETING CONTINUATION	$309,991
2024	2024	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	007	7	9/11/2024	SUPPLEMENT FOR EXPANSION	$300,249
2024	2024	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	006	7	8/15/2024	SUPPLEMENT FOR EXPANSION	$106,085
2024	2024	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	001	7	4/10/2024	NON-COMPETING CONTINUATION	$2,789,946
2024	2024	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	008	7	9/12/2024	NON-COMPETING CONTINUATION	$0
2024	2023	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	003	5	5/8/2024	NON-COMPETING CONTINUATION	-$6,700,000
2024	2023	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	004	6	5/8/2024	COMPETING CONTINUATION	$15,399,237
2024	2023	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	000	6	2/7/2024	COMPETING CONTINUATION	$0
2024	2021	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	002	4	5/8/2024	NON-COMPETING CONTINUATION	-$8,699,237
														Subtotal = $3,506,271

Issue Date FY: 2023 ( Subtotal = $12,149,937 )
2023	2023	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	008	6	8/25/2023	SUPPLEMENT FOR EXPANSION	$350,000
2023	2023	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	002	5	3/22/2023	NON-COMPETING CONTINUATION	$0
2023	2023	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	004	6	4/18/2023	COMPETING CONTINUATION	$0
2023	2023	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	010	6	9/1/2023	SUPPLEMENT FOR EXPANSION	$350,000
2023	2023	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	009	6	8/31/2023	SUPPLEMENT FOR EXPANSION	-$350,000
2023	2023	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	006	6	4/27/2023	SUPPLEMENT FOR EXPANSION	$2,000,000
2023	2023	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	001	5	2/10/2023	NON-COMPETING CONTINUATION	$6,700,000
2023	2023	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	005	5	4/27/2023	NON-COMPETING CONTINUATION	$0
2023	2023	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	007	5	6/5/2023	NON-COMPETING CONTINUATION	$0
2023	2023	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	003	6	3/29/2023	COMPETING CONTINUATION	$3,099,937
2023	2021	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	000	4	2/10/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $12,149,937

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	000	4	3/30/2022	NON-COMPETING CONTINUATION	$0
2022	2021	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	001	4	4/28/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $10,200,000 )
2021	2021	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	003	4	9/15/2021	NON-COMPETING CONTINUATION	$1,000,000
2021	2021	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	002	4	4/20/2021	NON-COMPETING CONTINUATION	$0
2021	2021	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	001	4	3/18/2021	NON-COMPETING CONTINUATION	$9,200,000
2021	2020	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	000	3	12/29/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $10,200,000

Issue Date FY: 2020 ( Subtotal = $13,700,000 )
2020	2020	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	3	9/9/2020	SUPPLEMENT FOR EXPANSION	$1,750,000
2020	2020	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	003	3	9/10/2020	NON-COMPETING CONTINUATION	$0
2020	2020	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	000	3	3/26/2020	NON-COMPETING CONTINUATION	$6,700,000
2020	2020	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	3	7/24/2020	SUPPLEMENT FOR EXPANSION	$5,250,000
														Subtotal = $13,700,000

Issue Date FY: 2019 ( Subtotal = $13,450,000 )
2019	2019	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	002	2	8/27/2019	NON-COMPETING CONTINUATION	$0
2019	2019	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	001	2	3/21/2019	NON-COMPETING CONTINUATION	$6,700,000
2019	2019	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	003	2	9/13/2019	SUPPLEMENT FOR EXPANSION	$6,750,000
2019	2018	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	000	1	1/21/2019	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $13,450,000

Issue Date FY: 2018 ( Subtotal = $14,240,433 )
2018	2018	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	002	1	8/26/2018	NEW	$0
2018	2018	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	001	1	7/9/2018	NEW	$6,040,433
2018	2018	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	003	1	9/14/2018	SUPPLEMENT FOR EXPANSION	$1,500,000
2018	2018	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	000	1	3/26/2018	NEW	$6,700,000
														Subtotal = $14,240,433

Grand Total All Awards = $67,246,641

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Neonatal Research Network Data Coordinating Center (DCC) 2023-2028

Award Number: U24HD095254

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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