# Cincinnati Outcomes of Babies with Opioid Exposure (OBOE)

> **NIH NIH RL1** · CINCINNATI CHILDRENS HOSP MED CTR · 2020 · $1

## Abstract

Opioid use during pregnancy is a national epidemic. Prenatal opioid exposure occurs at a time of 
rapid fetal brain development, and may cause important long-term structural and functional 
neurologic problems in the exposed child. However, children with prenatal opioid exposure 
are also often exposed to maternal mental health problems, poor parenting, and adverse home 
environments. It is critical to determine the relative impacts of multiple adverse exposures on 
childhood outcomes and identify potentially modifiable factors.
The goal of the Outcomes of Babies with Opioid Exposure (OBOE) study is to 
characterize the multidimensional impact of prenatal opioid exposure and to identify modifiable 
risk factors for adverse sequelae in order to optimize neurodevelopmental, behavioral, and family 
outcomes. Specific aims are: (1) To determine the impact of prenatal opioid exposure on brain 
structure and connectivity over the first 2 years of life, (2) To define medical, developmental, 
and behavioral outcomes over the first 2 years of life in infants exposed to opioids, 
and (3) To explore whether and how the home environment, maternal mental health, and parenting 
modify trajectories of brain connectivity and neurodevelopment over the first 2 years of life.
We hypothesize that neural connectivity and neuroanatomical volumes are altered by 
prenatal opioid exposure and that the magnitude of these alterations correlate with developmental 
and behavioral outcomes. Further, family and environmental factors interact with prenatal opioid 
exposure to influence the trajectories of connectivity, development, and behavior over the first 2 
years of life. To test this hypothesis, our consortium will enroll 200 opioid exposed infants 
and 75 healthy appropriately matched controls in a multicenter longitudinal cohort study. 
We will assess brain volumes and structural and functional connectivity by MRI at
2 weeks, 6 months, and 24 months and behavior and development at 12 and 24 months. 
 The home environment will be assessed with a standardized tool at 12 months.
Our consortium consists of a Data Coordinating Center at RTI and four Clinical Sites, all of whom 
have extensive experience collaborating in multicenter longitudinal pediatric research. 
Study team members have significant expertise in longitudinal neonatal follow-up, epidemiology, 
clinical trials, health disparities, neuroimaging, and neonatal opioid withdrawal syndrome (NOWS). 
The Clinical Site at Cincinnati Children's brings essential research expertise related to NOWS, 
experience with longitudinal follow-up of high-risk populations including opioid-exposed infants, 
innovative experience in neuroimaging, and an exceptional track record of recruitment and retention
in neonatal clinical research to the OBOE consortium, ensuring success of this important study.

## Key facts

- **NIH application ID:** 10141404
- **Project number:** 1RL1HD104254-01
- **Recipient organization:** CINCINNATI CHILDRENS HOSP MED CTR
- **Principal Investigator:** STEPHANIE L MERHAR
- **Activity code:** RL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1
- **Award type:** 1
- **Project period:** 2019-10-01 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10141404

## Citation

> US National Institutes of Health, RePORTER application 10141404, Cincinnati Outcomes of Babies with Opioid Exposure (OBOE) (1RL1HD104254-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10141404. Licensed CC0.

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