# Neonatal Treatment Trial

> **NIH NIH UG1** · CHILDREN'S HOSP OF PHILADELPHIA · 2024 · $264,000

## Abstract

PROJECT SUMMARY
Neonatal Opioid Withdrawal Syndrome (NOWS) is a major public health problem in the USA. About 100,000
American infants were exposed to opioids in 2017 and 25,000 of these infants were diagnosed with NOWS.
Opioid-exposed infants have poorer outcomes compared to similar non-exposed infants including longer and
more complicated initial hospital stays, higher likelihood of involvement in the child welfare system, higher
rates of hospital readmission and emergency department visits, and lower use of recommended preventive
services. One group of infants at particularly high risk for adverse outcomes are infants who receive
pharmacological therapy to treat signs of withdrawal. Importantly, the care, treatment, and outcomes of these
infants vary widely between birth hospitals and US states. Such variation suggests that the optimal
pharmacological treatment for NOWS remains unknown, potentially exposing these infants to unnecessary or
ineffective management.
The NOWS Treatment Trial will assess the optimal pharmacological treatment for NOWS through a
multicenter, comparative effectiveness trial comparing three commonly used medications. This application
describes the CHOP/Penn Neonatal Clinical Trials Network, our outstanding team of investigators with vast
clinical trial experience, our unparalleled research environment, and our large and diverse patient population
which together ensure that we are ideally suited to participate in the design and execution of the NOWS
Treatment Trial. We will contribute expertise in clinical trial methodology, substance abuse, and neonatal
follow-up, providing rigorous scientific input into design and implementation of the multicenter NOWS
Treatment Trial. We will then execute all aspects of the trial to the highest standard, including robust participant
recruitment, rigorous adherence to all aspects of the study protocol, and neurodevelopmental follow-up to two
years with minimal attrition.

## Key facts

- **NIH application ID:** 10916554
- **Project number:** 5UG1HD107631-03
- **Recipient organization:** CHILDREN'S HOSP OF PHILADELPHIA
- **Principal Investigator:** Sara Bonamo DeMauro
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $264,000
- **Award type:** 5
- **Project period:** 2021-09-17 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10916554

## Citation

> US National Institutes of Health, RePORTER application 10916554, Neonatal Treatment Trial (5UG1HD107631-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10916554. Licensed CC0.

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