# ACT-NOW Data Sustainability - ECHO Administrative Supplement

> **NIH NIH U2C** · DUKE UNIVERSITY · 2022 · $99,877

## Abstract

ABSTRACT
The incidence of neonatal opioid withdrawal syndrome (NOWS) increased greater than 5-fold between 2004 to
2014. Despite the significance of this problem, numerous critical gaps remain with respect to the best practices
for identification and management of infants with NOWS, along with our understanding of the outcomes of
these infants. Variation in pediatric medical care is common and contributes to differences in patient outcomes.
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. We are leveraging the ISPCTN and the NRN
to complete two clinical trials to evaluate interventions to improve the care of infants and families affected by
NOWS: 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 (24 site,
>1000 infants); 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 (25 sites, 500 infants). The goal
of this project is to develop data standards for use in clinical research within the infants with in utero opioid
exposure community. We will provide common data elements (CDEs) and reporting formats to assist
researchers quantify the severity of withdrawal among infants with NOWS using the Finnegan Neonatal
Abstinence Scoring Tool (FNAST) or the ESC from the ESC Trial. We will develop harmonized severity of
withdrawal among infants with NOWS definitions for clinical research and patient registries by using existing
data elements and creating new data elements, when needed.

## Key facts

- **NIH application ID:** 10628516
- **Project number:** 3U2COD023375-07S1
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** Laura Kristin NEWBY
- **Activity code:** U2C (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $99,877
- **Award type:** 3
- **Project period:** 2016-09-21 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10628516

## Citation

> US National Institutes of Health, RePORTER application 10628516, ACT-NOW Data Sustainability - ECHO Administrative Supplement (3U2COD023375-07S1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10628516. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*