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HEAL Initiative: Antenatal Opioid Exposure Longitudinal Study Consortium

Award Number: UG1HD104252
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: 10/01/2019
PERIOD OF PERFORMANCE END DATE: 06/30/2027

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HEAL Initiative: Antenatal Opioid Exposure Longitudinal Study Consortium - ABSTRACT Neonatal Opioid Withdrawal Syndrome (NOWS) is a major public health problem in the USA. Since 2000- 2012, the incidence of NOWS has increased five-fold to almost 6 per 1,000 hospital births and the associated health care expenditures have increased from $200 million to $1.5 billion. Limited data are available on the effects of antenatal opioid exposure on the brain and neurodevelopment because of small sample sizes and difficulty controlling for important environmental variables. The OBOE (Outcomes of Babies with Opioid Exposure) study, an ongoing NICHD-funded longitudinal study enrolling infants with and without antenatal opioid exposure at birth and following them to two years of age, attempts to address these limitations by collecting comprehensive exposure data from parental report and from infant umbilical cord analysis; advanced neuroimaging data to evaluate brain development; standardized information on the home environment, maternal mental health, and parenting; and neuro- developmental outcomes to 2 years of age. The OBOE consortium, comprised of 4 highly performing clinical centers, a data coordinating center, and a neuroimaging core, has completed our goal enrollment of 200 opioid-exposed infants and 100 unexposed infants. In response to RFA-HD-24-014, we now propose to complete follow-up to age two years in our OBOE cohort to fulfill our main study objectives. The CHOP/PENN site has enrolled 46 infants (34 exposed and 12 controls), completing 53 MRIs across 2 timepoints thus far, contributing to the publication of multiple abstracts and three manuscripts using OBOE data, and developing the CONSENTER intervention to improve recruitment of exposed and control patients. For this renewal grant, we will continue progress toward our aims to: 1) determine the impact of antenatal opioid exposure on brain structure and connectivity over the first two years of life; 2) define medical, developmental, and behavioral trajectories over the first two years of life in exposed infants; and 3) determine how the home environment, maternal mental health, and parenting modify trajectories of brain connectivity and neurodevelopment over the first two years of life. Our progress so far, with enrollment completed and success in following this difficult population, shows that we can successfully complete the objectives of the OBOE study.


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 = $141,674 )
2025	2025	THE CHILDREN'S HOSPITAL OF PHILADELPHIA	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Child Health and Human Development Extramural Research	000	3	7/14/2025	NON-COMPETING CONTINUATION	$141,674
														Subtotal = $141,674

Issue Date FY: 2024 ( Subtotal = $178,000 )
2024	2024	THE CHILDREN'S HOSPITAL OF PHILADELPHIA	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Child Health and Human Development Extramural Research	000	2	7/26/2024	COMPETING CONTINUATION	$178,000
														Subtotal = $178,000

Grand Total All Awards = $319,674

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HEAL Initiative: Antenatal Opioid Exposure Longitudinal Study Consortium

Award Number: UG1HD104252

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: 10/01/2019

PERIOD OF PERFORMANCE END DATE: 06/30/2027

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