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Data Coordinating Center (DCC) for the Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial (NOWS PhaCET)

Award Number: U24HD107621
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/20/2021
PERIOD OF PERFORMANCE END DATE: 08/31/2027

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Data Coordinating Center (DCC) for the Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial (NOWS PhaCET) - PROJECT SUMMARY/ABSTRACT Major knowledge gaps exist in optimizing pharmacologic treatment for neonatal opioid withdrawal syndrome (NOWS), a pressing public health issue. Rigorous, high quality, randomized trials are urgently needed to develop the evidence base and best practices for neonatal medicine in this area. In response, the NICHD Heal Initiative NOWS Pharmacological Treatments Comparative Effectiveness Trial (NOWS PhaCET) consortium will design and implement a multi-center, comparative effectiveness, randomized controlled trial (RCT) to assess the optimal pharmacological treatment for NOWS that informs clinical practice guidelines. There is a crucial need for an independent and experienced Data Coordinating Center (DCC) to provide high-quality and impartial biostatistical expertise to address the substantial methodologic challenges in the design and conduct of such a trial by (1) building consensus to help identify critical methodologic issues; (2) bringing objective statistical expertise to the conception, design, and analyses of a rigorous and feasible randomized trial (with appropriate monitoring); (3) developing processes and systems to increase the efficiency of the consortium, ensure trial feasibility, and effective use of limited trial participants and resources; (4) ensuring standardization of study design, development, data collection, data quality, and data analyses with existing HEAL activities; and (5) dissemination of study results, public reports, and public use data. As longtime DCC for the NICHD Neonatal Research Network (NRN) and the ongoing Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) studies, RTI has successfully collaborated in the design and implementation of 30+ RCTs in neonates informing clinical practice. Our Specific Aims as the DCC for NOWS PhaCET are to (1) Enhance the scientific rigor of the consortium by collaboratively building consensus for a uniform protocol that addresses the unique feasibility and implementation challenges of pharmacological RCTs in NOWS; (2) Optimize productivity with flexible, efficient, and high quality data and study management, and promote HEAL data harmonization and sharing; (3) Protect participant safety and study integrity working with the independent Data Safety and Monitoring Committee (DSMC), single IRB (sIRB), NICHD, and FDA (as needed); (4) Provide timely reporting and data analysis, and collaborate with investigators on all consortium analyses and publications; and (5) Provide the necessary logistical, contractual, communications, and regulatory support. The unique strengths of this application include (1) a highly qualified PI and staff uniquely experienced in all aspects of both neonatal and NOWS trials including neurodevelopmental follow-up; (2) proven track record of collaboration and scientific productivity in perinatal studies; (3) state-of-the-art infrastructure of flexible tools, processes, and systems customized for neonatal/ NOWS RCTs incorporating follow-up; (4) multidisciplinary experts available as needed; and (5) depth and breadth of expert staff with an agile administrative structure that can respond quickly to changing 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 = $1 )
2025	2025	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	000	4	8/20/2025	NON-COMPETING CONTINUATION	$1
														Subtotal = $1

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	004	3	9/20/2024	NON-COMPETING CONTINUATION	$0
2024	2023	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	000	3	11/22/2023	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	3	9/13/2024	NON-COMPETING CONTINUATION	$0
2024	2023	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	002	3	3/8/2024	NON-COMPETING CONTINUATION	$0
2024	2023	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	001	3	2/28/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $10,225,990 )
2023	2023	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	001	3	8/23/2023	NON-COMPETING CONTINUATION	$10,225,990
2023	2022	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	000	2	2/22/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $10,225,990

Issue Date FY: 2022 ( Subtotal = $12,000,000 )
2022	2022	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	000	2	8/5/2022	NON-COMPETING CONTINUATION	$12,000,000
														Subtotal = $12,000,000

Issue Date FY: 2021 ( Subtotal = $3,402,723 )
2021	2021	RESEARCH TRIANGLE INSTITUTE	3040 E CORNWALLIS RD	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	000	1	9/20/2021	NEW	$3,402,723
														Subtotal = $3,402,723

Grand Total All Awards = $25,628,714

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Data Coordinating Center (DCC) for the Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial (NOWS PhaCET)

Award Number: U24HD107621

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/20/2021

PERIOD OF PERFORMANCE END DATE: 08/31/2027

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