# CWRU Clinical Center - Outcomes of Babies with Opioid Exposure (OBOE) Study

> **NIH NIH UG1** · CASE WESTERN RESERVE UNIVERSITY · 2024 · $155,275

## Abstract

PROJECT SUMMARY/ABSTRACT
Limited data are available on the effects of antenatal opioid exposure on the brain and
neurodevelopment. Most studies are limited by methodologic flaws in study design, including 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 2 years of age, attempts to improve on the limitations of previous research
by collecting comprehensive exposure data including infant umbilical cords, advanced neuroimaging data to
evaluate brain development, and standardized and thorough information on the home environment, maternal
mental health, and parenting. The OBOE consortium, comprised of 4 high performing centers, a data
coordinating center, and a neuroimaging core, has completed our goal enrollment of 200 opioid-exposed and
100 unexposed infants. In response to RFA-HD-24-014, we now propose to complete follow-up to age two in
our OBOE cohort, to fulfill our main study objectives. The Case site has contributed to the OBOE study by
enrolling 29 infants (24 opioid-exposed and 5 controls), completing 25 MRIs thus far, and contributing
to the publication of multiple abstracts and three manuscripts using OBOE data. 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 have the ability to successfully complete the objectives of the OBOE study.
Contact PD/PI: Wilson-Costello, Deanne
Project Summary/

## Key facts

- **NIH application ID:** 11002034
- **Project number:** 2UG1HD104253-02
- **Recipient organization:** CASE WESTERN RESERVE UNIVERSITY
- **Principal Investigator:** Anna Maria Hibbs
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $155,275
- **Award type:** 2
- **Project period:** 2019-10-01 → 2027-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11002034

## Citation

> US National Institutes of Health, RePORTER application 11002034, CWRU Clinical Center - Outcomes of Babies with Opioid Exposure (OBOE) Study (2UG1HD104253-02). Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/grant/nih/11002034. Licensed CC0.

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