# ECHO Administrative Supplement - Neonatal Opioid Trials

> **NIH NIH U2C** · DUKE UNIVERSITY · 2021 · $1,500,000

## Abstract

Neonatal opioid withdrawal syndrome (NOWS) has increased more than fivefold since 2000. The dramatic rise
in NOWS has occurred in association with an increase in the use of opioids by pregnant women. Little is
known about the best methods for identification, monitoring, and treatment of affected infants. The IDeA States
Pediatric Clinical Trials Network (ISPCTN), which is part of the Environmental influences on Child Health
Outcomes (ECHO) Program, and the Neonatal Research Network (NRN) are uniquely poised to address
existing knowledge gaps associated with NOWS. The ISPCTN consists of >20 neonatal intensive care units
and the NRN consists of >50 neonatal intensive care units. Both networks have access to investigators, study
coordinators, infrastructure, and participants for clinical trials. The Duke Clinical Research Institute (DCRI)
serves as the ECHO Coordinating Center and has extensive experience in cohort studies and clinical trials in
infants. We will also leverage the expertise of the Data Coordinating and Operations Center (DCOC) of the
ISPCTN at the University of Arkansas for Medical Sciences (UAMS). The overall goal of our proposal is to use
the infrastructure of the ECHO Program and ISPCTN in collaboration with the NRN to initiate two clinical trials
to evaluate interventions to improve the care of infants and families affected by NOWS. Our research team, led
by Drs. Brian Smith and Rachel Greenberg at DCRI and Drs. Jeannette Lee and Jessica Snowden at UAMS,
will achieve this goal by implementing: 1) a clinical trial protocol evaluating the optimal use of the Eating,
Sleeping, Consoling (ESC) care approach on the length of time until infants affected by NOWS are medically
ready for discharge; and 2) a clinical trial protocol evaluating whether an early stop weaning protocol for
morphine in infants treated for NOWS will decrease the number of days of opioid treatment. Using the highest
research standards, we will accomplish the task set out by the NIH to close research gaps in this critically
important area.
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## Key facts

- **NIH application ID:** 10459783
- **Project number:** 3U2COD023375-06S1
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** Laura Kristin NEWBY
- **Activity code:** U2C (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,500,000
- **Award type:** 3
- **Project period:** 2016-09-21 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10459783

## Citation

> US National Institutes of Health, RePORTER application 10459783, ECHO Administrative Supplement - Neonatal Opioid Trials (3U2COD023375-06S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10459783. Licensed CC0.

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