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Nebraska Pediatric Clinical Trials Unit

Award Number: UG1OD024953
ORGANIZATION: OFFICE OF THE DIRECTOR, NIH
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/23/2016
PERIOD OF PERFORMANCE END DATE: 05/31/2030

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Nebraska Pediatric Clinical Trials Unit - Although clinical trials are the highest standard of evidence for the effectiveness and safety of medical interventions, children often receive medical therapies that have never been studied in clinical trials involving pediatric subjects. Knowledge of the etiology, prevention, and/or treatment of these illnesses often must be extrapolated from adult-derived data. Children often respond to medications differently from adults due to differences in physiology and drug metabolism, placing them at increased risk of experiencing adverse, even life-threatening events from off-label medical treatment use. Clinical trials furnish patients opportunities to receive well-supervised treatments and procedures before they are widely available, gain improved understanding of their health conditions, and contribute to knowledge that benefits others. Importantly for IDeA states like Nebraska, children from communities with lower access to advanced medicine (e.g., rural regions) are less likely to have access to clinical trials. During the first two cycles of the ECHO IDeA States Pediatric Clinical Trials Network (ISPCTN), the Nebraska Pediatric Clinical Trials Unit (NPCTU) has led the first network-developed randomized controlled trial, enrolled participants in almost all ISPCTN studies, and expanded human and organizational capital in Nebraska to conduct clinical trials statewide. The NPCTU is poised to build upon this success to ensure that all Nebraska children have access to clinical trials. We propose the following Specific Aims to drive continued growth in clinical trials access and participation for Nebraska children: (1) Develop, conduct, and disseminate findings from multicenter clinical trials research, assuring the participation of children living in IDeA states. The NPCTU will solicit trial proposals from community stakeholders and faculty and propose at least three multicenter clinical trial concepts to the ISPCTN, participate in implementing all five anticipated multicenter network trials, including our proposed trial to test the effectiveness of a multi-level mHealth-based intervention to increase adherence to recommended infant immunizations and lab screenings. (2) Build pediatric clinical trial research capacity at the clinical site. The NPCTU will continue to expand clinical trials performance capabilities by enacting a multifaceted training and mentoring plan for developing early-stage faculty into proficient leaders of multicenter clinical trials and train clinical and research staff to conduct trials. (3) Engage interested parties such as community members, nonprofit organizations, and professional societies to enhance ECHO ISPCTN clinical trial impact, transferability, rigor, and feasibility. The NPCTU will sustain and build on our robust engagements with professional societies that issue pediatric clinical practice guidelines and with a wide range of individual- and organization-level community stakeholders. Existing and new collaborations will provide rich insight into communities’ research priorities, help us deploy trials in ways that more fully engage Nebraska children, and disseminate results back to communities.


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: 2027 ( Subtotal = $0 )
2027	2026	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	4215 EMILE ST	OMAHA	NE	68105	DOUGLAS	USA	Trans-NIH Research Support	000	9	10/28/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2026 ( Subtotal = $355,742 )
2026	2026	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	4215 EMILE ST	OMAHA	NE	68105	DOUGLAS	USA	Trans-NIH Research Support	002	9	6/16/2026	NON-COMPETING CONTINUATION	$355,742
2026	2025	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	4215 EMILE ST	OMAHA	NE	68105	DOUGLAS	USA	Trans-NIH Research Support	001	8	4/14/2026	COMPETING CONTINUATION	$0
2026	2024	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	4215 EMILE ST	OMAHA	NE	68105	DOUGLAS	USA	Trans-NIH Research Support	000	7	1/9/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $355,742

Issue Date FY: 2025 ( Subtotal = $425,401 )
2025	2025	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	4215 EMILE ST	OMAHA	NE	68105	DOUGLAS	USA	Trans-NIH Research Support	002	8	8/18/2025	COMPETING CONTINUATION	$425,401
2025	2024	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	4215 EMILE ST	OMAHA	NE	68105	DOUGLAS	USA	Trans-NIH Research Support	001	7	8/15/2025	NON-COMPETING CONTINUATION	$0
2025	2024	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	4215 EMILE ST	OMAHA	NE	68105	DOUGLAS	USA	Trans-NIH Research Support	000	7	7/15/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $425,401

Issue Date FY: 2024 ( Subtotal = $400,241 )
2024	2024	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Trans-NIH Research Support	001	7	8/28/2024	NON-COMPETING CONTINUATION	$400,241
2024	2023	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Trans-NIH Research Support	000	6	5/6/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $400,241

Issue Date FY: 2023 ( Subtotal = $404,915 )
2023	2023	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Trans-NIH Research Support	001	6	8/18/2023	NON-COMPETING CONTINUATION	$403,654
2023	2023	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Trans-NIH Research Support	002	6	9/18/2023	NON-COMPETING CONTINUATION	$1,261
2023	2022	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Trans-NIH Research Support	000	5	7/18/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $404,915

Issue Date FY: 2022 ( Subtotal = $408,819 )
2022	2022	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Trans-NIH Research Support	001	5	8/29/2022	NON-COMPETING CONTINUATION	$408,819
2022	2021	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Trans-NIH Research Support	000	4	1/21/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $408,819

Issue Date FY: 2021 ( Subtotal = $419,582 )
2021	2021	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Trans-NIH Research Support	004	4	8/26/2021	NON-COMPETING CONTINUATION	$418,178
2021	2020	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Trans-NIH Research Support	000	3	10/29/2020	COMPETING CONTINUATION	$1,404
2021	2020	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Trans-NIH Research Support	003	3	4/21/2021	COMPETING CONTINUATION	$0
2021	2020	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Trans-NIH Research Support	002	3	2/20/2021	COMPETING CONTINUATION	$210,223
2021	2016	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Child Health and Human Development Extramural Research	001	2	2/20/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$210,223
														Subtotal = $419,582

Issue Date FY: 2020 ( Subtotal = $428,072 )
2020	2020	BOARD OF REGENTS OF THE UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Trans-NIH Research Support	000	3	8/19/2020	COMPETING CONTINUATION	$428,072
														Subtotal = $428,072

Issue Date FY: 2017 ( Subtotal = $1,583,355 )
2017	2016	UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Child Health and Human Development Extramural Research	001	2	6/15/2017	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2017	2016	UNIVERSITY OF NEBRASKA	987835 NEBRASKA MEDICAL CENTER	OMAHA	NE	68198	DOUGLAS	USA	Child Health and Human Development Extramural Research	000	2	4/11/2017	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,583,355
														Subtotal = $1,583,355

Grand Total All Awards = $4,426,127

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Nebraska Pediatric Clinical Trials Unit

Award Number: UG1OD024953

ORGANIZATION: OFFICE OF THE DIRECTOR, NIH

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/23/2016

PERIOD OF PERFORMANCE END DATE: 05/31/2030

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