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HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial New Mexico Site

Award Number: UG1HD107627
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: 09/17/2021
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial New Mexico Site - Project Summary/Abstract The Neonatal Opioid Withdrawal Syndrome (NOWS) Pharmacological Treatments Comparative Effectiveness Trial is a multisite study that examine the long- and short-term outcomes for neonates with NOWS that require pharmacological treatment. The neonates will be randomized to three medications: buprenorphine, methadone and morphine. Short term outcomes are anticipated to include length of hospital stay and length of pharmacological treatment, with longer term outcomes including neonatal growth and neurodevelopment. The common protocol will be developed by a steering committee composed of the principal investigators from each participating clinical center. The trial will be designed to control for relevant clinical variables including the type of maternal opioid used, maternal polysubstance use including tobacco, the use of nonpharmacological treatments for NOWS, and the use of adjunctive nonopioid medications. The follow-up plan will be developed as part of the protocol and will extend until at least 24 months of age and include the use of specific neurodevelopmental assessment tools including the Bayley Scales of Infant and Toddler Development 4th Edition. The trial is designed to determine the optimal pharmacological treatment including the specific medication dosing and weaning regimen. The University of New Mexico Clinical Center will include infants treated for NOWS across all neonatal care sites including the mother baby unit where dyadic room-in care is provided, the intermediate care nursery, and the neonatal intensive care unit. The standardization of pharmacological treatment for NOWS is anticipated to have significant public health benefits including decreasing length of hospital stay, decreasing cost of treatment, and potentially improving long term neurodevelopmental outcomes.


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: 2026 ( Subtotal = $0 )
2026	2025	UNIVERSITY OF NEW MEXICO	1 UNIVERSITY OF NEW MEXICO	ALBUQUERQUE	NM	87131	BERNALILLO	USA	Child Health and Human Development Extramural Research	000	4	1/28/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $222,694 )
2025	2025	UNIVERSITY OF NEW MEXICO	1 UNIVERSITY OF NEW MEXICO	ALBUQUERQUE	NM	87131	BERNALILLO	USA	Child Health and Human Development Extramural Research	000	4	8/20/2025	NON-COMPETING CONTINUATION	$222,694
														Subtotal = $222,694

Issue Date FY: 2024 ( Subtotal = $222,694 )
2024	2024	UNIVERSITY OF NEW MEXICO	1 UNIVERSITY OF NEW MEXICO	ALBUQUERQUE	NM	87131	BERNALILLO	USA	Child Health and Human Development Extramural Research	003	3	8/15/2024	NON-COMPETING CONTINUATION	$222,694
2024	2023	UNIVERSITY OF NEW MEXICO	1 UNIVERSITY OF NEW MEXICO	ALBUQUERQUE	NM	87131	BERNALILLO	USA	Child Health and Human Development Extramural Research	002	2	1/29/2024	EXTENSION WITH OR WITHOUT FUNDS	$0
2024	2023	UNIVERSITY OF NEW MEXICO	1 UNIVERSITY OF NEW MEXICO	ALBUQUERQUE	NM	87131	BERNALILLO	USA	Child Health and Human Development Extramural Research	001	2	12/21/2023	EXTENSION WITH OR WITHOUT FUNDS	$168,810
2024	2021	UNIVERSITY OF NEW MEXICO	1 UNIVERSITY OF NEW MEXICO	ALBUQUERQUE	NM	87131	BERNALILLO	USA	Child Health and Human Development Extramural Research	000	1	12/21/2023	NEW	-$168,810
														Subtotal = $222,694

Issue Date FY: 2023 ( Subtotal = $222,694 )
2023	2023	UNIVERSITY OF NEW MEXICO	1 UNIVERSITY OF NEW MEXICO	ALBUQUERQUE	NM	87131	BERNALILLO	USA	Child Health and Human Development Extramural Research	001	2	8/31/2023	EXTENSION WITH OR WITHOUT FUNDS	$222,694
2023	2021	UNIVERSITY OF NEW MEXICO	1 UNIVERSITY OF NEW MEXICO	ALBUQUERQUE	NM	87131	BERNALILLO	USA	Child Health and Human Development Extramural Research	000	1	11/30/2022	NEW	$0
														Subtotal = $222,694

Issue Date FY: 2021 ( Subtotal = $445,388 )
2021	2021	UNIVERSITY OF NEW MEXICO	2500 MARBLE DR NE	ALBUQUERQUE	NM	87131	BERNALILLO	USA	Child Health and Human Development Extramural Research	000	1	9/17/2021	NEW	$445,388
														Subtotal = $445,388

Grand Total All Awards = $1,113,470

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HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial New Mexico Site

Award Number: UG1HD107627

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: 09/17/2021

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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