ACT NOW

Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW)

Small image of newborn being comfortedACT NOW Research Studies

ECHO researchers are part of two current ACT NOW studies, and participated in another that is now complete. These studies launched in Spring 2021 and aim to determine the best ways for hospitals to care for babies with NOWS.

https://dash.nichd.nih.gov/study/ 229026

Study Purpose The goal of the ACT NOW Current Experience (CE) Study was to describe patient and practice variation in the care of infants with Neonatal Opioid Withdrawal Syndrome (NOWS).


NCT # 04057820
https://clinicaltrials.gov/ct2/ show/NCT04057820

Study Purpose The goal of the ACT NOW ESC study is to test whether the “Eat, Sleep, Console” (ESC) care approach is more effective than usual approaches to assess and manage care for opioid-exposed newborns. ESC prioritizes care without the use of medications, such as a low-stimulation environment, swaddling, skin-to-skin contact, and breastfeeding.

View the protocol.

NCT # 04214834
https://clinicaltrials.gov/ct2/ show/NCT04214834

Study Purpose The goal of the ACT NOW Weaning Study is to help clinicians safely reduce doses of morphine or methadone prescribed to infants with Neonatal Opioid Withdrawal Syndrome (NOWS).

Questions

Questions about ECHO's involvement in the ACT NOW Program or NIH HEAL Initiative® can be directed to the Program Office.

The ACT NOW Program

Funded through The Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, the ACT NOW research program aims to test the ways babies with NOWS are assessed, treated, and followed long-term, so that the infants can get the best possible care.

The program is a collaborative effort of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network (NRN) and the ECHO IDeA States Pediatric Clinical Trials Network (ISPCTN).

The importance of NOWS research

When a woman uses opioids during pregnancy, her baby may be born with a condition called Neonatal Opioid Withdrawal Syndrome (NOWS). The withdrawal symptoms for these babies can include tremors; excessive crying and irritability; and problems with sleeping, feeding, and breathing.

There are currently few standard, evidence-based treatments for NOWS, and doctors and researchers still don’t know much about the long-term effects of this condition.

ACT NOW Program News

New Collaborative ECHO Research Demonstrates Effectiveness of “Eat, Sleep, Console” Approach in Caring for Newborns with Neonatal Opioid Withdrawal Syndrome

April 30, 2023

A collaborative effort between the NIH’s NICHD Neonatal Research Network and the ECHO Program’s ISPCTN found that the “Eat, Sleep, Console” (ESC) care approach is more effective for the treatment of newborns with neonatal opioid withdrawal syndrome (NOWS) than usual approaches to care. This research was led by ISPCTN investigators Leslie Young, MD of the University of Vermont; and Lori Devlin, DO, MHA, MS of the University of Louisville School of Medicine, ...

 

ECHO Study Examines Characteristics Associated with Opioid Use During Pregnancy

November 14, 2022

Collaborative ECHO research led by Ruby Nguyen, PhD of the University of Minnesota and Monica McGrath, ScD of Johns Hopkins University Bloomberg School of Public Health, described characteristics that were associated with opioid using during pregnancy. The study included over 20,000 pregnant people from across the United States and found that the majority of individuals who used opioids during pregnancy were non-Hispanic White and college educated. ...

 

ECHO ACT NOW Current Experience Manuscript Published in Pediatrics

February 2, 2021

In December, the ECHO IDeA States Pediatric Clinical Trials Network (ISPCTN) published its first ACT NOW Current Experience manuscript, “Site-Level Variation in the Characteristics and Care of Infants with Neonatal Opioid Withdrawal,” in Pediatrics. The ACT NOW (Advancing Clinical Trials in Neonatal Opioid Withdrawal) Current Experience Study is designed to describe variation in the care of infants with neonatal opioid withdrawal ...

 

Establishing a Standard of Care for Babies Born Dependent on Opioids

July 22, 2020

Lead Investigators: Leslie Young, University of Vermont, Lori Devlin, University of Louisville, Stephanie Merhar, University of Cincinnati As the opioid epidemic continues to affect families across the United States, opioid exposure in the womb has attracted more attention. When a woman uses opioids while she is pregnant, her newborn baby can have symptoms of withdrawal such as intense fussiness, inability to ...

 

ECHO Researchers Identify Gaps in Prenatal Opioid Exposure Research

August 28, 2019

This week, Pediatrics published results from ECHO researcher Elisabeth Conradt and her team’s efforts to learn more about prenatal opioid exposure and its effects on child development. Conradt and her team reviewed 52 publications to summarize what is known and make suggestions on how to expand knowledge in this area. The resulting article includes perspectives on how the ECHO Program ...

 

Addressing the impact of opioids on women and children

August 01, 2019

Women and children bear a substantial part of the burden of opioid overuse in the United States. Opioid use during pregnancy can lead to neonatal opioid withdrawal syndrome, and both the mothers and babies may be at higher risk of opioid use and its consequences later in the life course, setting up intergenerational cycles of opioid overuse. ...

NIH-Funded Study to Focus on Newborns Affected by Opioids

October 2, 2017

Experts plan clinical trial to test treatments for withdrawal syndrome. The National Institutes of Health is funding a new study to evaluate treatment options for newborns with opioid withdrawal syndrome, a condition caused by exposure to opioids during pregnancy. Currently, health care providers in the United States lack standard, evidence-based treatments for neonatal opioid withdrawal syndrome, despite states reporting more cases in recent ...
Research Summaries

Resources

National Institute of Drug Abuse (NIDA)

Centers for Disease Control and Prevention (CDC)

  • CDC Drug Overdose Literature: Comprehensive resource designed for non‐health professionals. Includes helpful glossary of commonly‐used terms.
  • CDC Opioid Use During Pregnancy: CDC resource about opioid use during pregnancy; treatments before, during and after pregnancy; and data and statistics (Materials in English and Spanish).

Health and Human Services (HHS)

Food and Drug Administration (FDA)