Sunday, August 17, 2025 8/17/2025

Vital Signs In Opioid-Exposed Neonates

Award Number: R01HD105205
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/24/2021
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Vital Signs In Opioid-Exposed Neonates - Project Summary Rates of opioid use during pregnancy are at epidemic proportions. Infants exposed to opioids before birth frequently develop neonatal opioid withdrawal syndrome (NOWS) and are at a much higher risk of sudden infant death syndrome (SIDS). A major knowledge gap is that it not currently possible to determine the magnitude of NOWS or SIDS risk in opioid-exposed infants. Most infants with antenatal opioid exposure are observed for several days after birth in the hospital to determine if the infant develops NOWS. Infants who develop NOWS are frequently managed using the Finnegan scoring system which is complex and subjective. There is therefore a need for rapid objective and quantitative measurement of signs of opioid withdrawal. There is a critical need to determine if the hospital course of NOWS or abnormalities in respiratory control can be predicted soon after birth, in order to initiate earlier monitoring or therapy. Furthermore, it is essential to be able to adjust therapy in a more evidence-based manner. The overall objective of the Vital Signs In Opioid-exposed Neonates (ViSION) project is to use cardiorespiratory dynamics (characteristics and patterns of heart rate, respiratory rate, and oxygen saturations) soon after birth from the existing large cohort of opioid-exposed newborns (>140/yr) at the University of Alabama at Birmingham to develop and validate mathematical models to predict (a) onset of NOWS, (b) changes in magnitude of NOWS as estimated by Finnegan scoring, and (c) abnormal polysomnographic (sleep) study at three months of age. The central hypothesis of this proposed study is that cardiorespiratory dynamics improve detection of NOWS onset and severity, and can predict infants with sleep disordered breathing before discharge. The Specific Aims are: Specific Aim 1: Test the hypothesis that cardiorespiratory dynamics soon after birth identify opioid-exposed neonates at higher risk of neonatal opioid withdrawal syndrome. This hypothesis will be tested in a prospective cohort of 200 opioid-exposed newborn infants and 100 healthy control infants. Specific Aim 2: Test the hypothesis that cardiorespiratory dynamics of infants diagnosed with neonatal opioid withdrawal syndrome track temporally with clinical assessment by the Finnegan scoring. This hypothesis will be tested in a prospective cohort of 100 newborn infants diagnosed with neonatal opioid withdrawal syndrome. Specific Aim 3: Test the hypothesis that intermittent hypoxemia and bradycardia events soon after birth are associated with apnea-hypopnea index on polysomnographic studies at three months of age. This hypothesis will be tested in a prospective cohort of 60 newborn infants diagnosed with NOWS, 60 opioid-exposed infants without NOWS, and 60 healthy control infants.


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 = $507,733 )
2025	2025	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Child Health and Human Development Extramural Research	000	5	7/17/2025	NON-COMPETING CONTINUATION	$507,733
														Subtotal = $507,733

Issue Date FY: 2024 ( Subtotal = $502,655 )
2024	2024	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Child Health and Human Development Extramural Research	000	4	8/14/2024	NON-COMPETING CONTINUATION	$502,655
														Subtotal = $502,655

Issue Date FY: 2023 ( Subtotal = $507,733 )
2023	2023	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Child Health and Human Development Extramural Research	000	3	8/10/2023	NON-COMPETING CONTINUATION	$507,733
														Subtotal = $507,733

Issue Date FY: 2022 ( Subtotal = $507,733 )
2022	2022	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Child Health and Human Development Extramural Research	001	2	8/29/2022	NON-COMPETING CONTINUATION	$507,733
2022	2021	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Child Health and Human Development Extramural Research	000	1	11/1/2021	NEW	$0
														Subtotal = $507,733

Issue Date FY: 2021 ( Subtotal = $519,859 )
2021	2021	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Child Health and Human Development Extramural Research	000	1	9/23/2021	NEW	$519,859
														Subtotal = $519,859

Grand Total All Awards = $2,545,713

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Vital Signs In Opioid-Exposed Neonates

Award Number: R01HD105205

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/24/2021

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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