# Thomas Jefferson University Hospital Clinical Site for HEAL NOWS Pharmacologic Trial

> **NIH NIH UG1** · THOMAS JEFFERSON UNIVERSITY · 2021 · $316,232

## Abstract

Project Summary
Thomas Jefferson University Hospital (TJUH) is the main clinical campus of Thomas Jefferson
University (TJU) and will serve as clinical site for the “HEAL Initiative: Neonatal Opioid Withdrawal
Syndrome Pharmacological Treatments Comparative Effectiveness Trial - Clinical Sites” RFA-
HD-21=031. The site will be led by the co-PI structure of Walter Kraft, MD (TJU) and Susan
Adeniyi-Jones, MD (TJU and Nemours at Jefferson). TJU has a 40-year history of leadership in
optimizing approaches to the care opioid use disorder in pregnancy at the Maternal Addiction
Treatment, Education, and Research (MATER) program, which carries a maternal census of >200
women. The current investigative team has been leaders in conducting clinical trials examining
the optimal pharmacological treatments for neonatal opioid withdrawal syndrome (NOWS). This
work has included neonatal first use and pharmacometric driven dose optimization of
buprenorphine. TJU was the national top enroller in the recently completed AIM2NAS study
examining ondansetron as pharmacologic adjunct to reduce NOWS symptoms. These clinical
trials, along with work in genetic sample collection, have enrolled over 450 infants in NOWS
related research. TJUH engages in maximal non-pharmacologic care and has a well-established
quality assessment and improvement program around NOWS care. There is a robust continuum
of care that supports women with opioid use disorders before, during, and after delivery. This
supportive culture has resulted in high rate of agreeing to participate in clinical trials (~70% of
mothers approached) allows for longitudinal follow up of infants. Neurodevelopmental
assessment is available for infants across the tri-state region catchment area of Philadelphia. The
investigative team is experienced in the conduct and design of multi-center clinical trials and of
data safety monitoring board functioning. The investigators have has been involved in national
and international consortia dedicated to optimizing care in NOWS.

## Key facts

- **NIH application ID:** 10378979
- **Project number:** 1UG1HD107628-01
- **Recipient organization:** THOMAS JEFFERSON UNIVERSITY
- **Principal Investigator:** Susan Adeniyi-Jones
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $316,232
- **Award type:** 1
- **Project period:** 2021-09-17 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10378979

## Citation

> US National Institutes of Health, RePORTER application 10378979, Thomas Jefferson University Hospital Clinical Site for HEAL NOWS Pharmacologic Trial (1UG1HD107628-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10378979. Licensed CC0.

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