# HEAL initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial: Cincinnati site

> **NIH NIH UG1** · CINCINNATI CHILDRENS HOSP MED CTR · 2024 · $230,691

## Abstract

PROJECT SUMMARY/ABSTRACT
The number of infants exposed to opioids prenatally in the US remains high, with one infant born exposed to
opioids every 15 minutes. Optimal treatment for exposed infants who develop neonatal opioid withdrawal
syndrome (NOWS) has not been established, and randomized comparative effectiveness trials of medications
for NOWS are critically needed. Cincinnati Children’s Hospital Medical Center (CCHMC) is uniquely suited to
participate as a clinical site in such a multicenter randomized comparative effectiveness trial. The CCHMC
Perinatal Institute is a large regional perinatal center, providing population-based clinical service for
approximately 25,000 newborns each year. Intrauterine exposure to opioids in the Cincinnati region was
approximately 26 per 1000 live births in 2020, with 10.3 per 1000 developing NOWS requiring pharmacologic
treatment. The proposed PI for this study Stephanie Merhar, proposed alternate PI Scott Wexelblatt, and
proposed follow-up PI Jennifer McAllister all have extensive experience in clinical care, quality improvement,
and clinical research in the NOWS population. The Cincinnati team will provide significant intellectual
contributions to the design of the study, recruit a large number of infants with NOWS to participate, and continue
our tradition of excellent follow-up rates to retain infants in the study to age 2. The expertise and experience of
the investigators and support staff, along with the facilities and population available for study at CCHMC, make
CCHMC a strong site for this proposed study.

## Key facts

- **NIH application ID:** 10916555
- **Project number:** 5UG1HD107616-03
- **Recipient organization:** CINCINNATI CHILDRENS HOSP MED CTR
- **Principal Investigator:** STEPHANIE L MERHAR
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $230,691
- **Award type:** 5
- **Project period:** 2021-09-17 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10916555

## Citation

> US National Institutes of Health, RePORTER application 10916555, HEAL initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial: Cincinnati site (5UG1HD107616-03). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10916555. Licensed CC0.

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