Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW)

Overview

The Research Need

Newborns exposed to opioids in the womb are at risk for a condition called neonatal opioid withdrawal syndrome (NOWS) or neonatal abstinence syndrome. NOWS symptoms can include tremors; excessive crying and irritability; and problems with sleeping, feeding, and breathing.

The incidence of NOWS in the United States has increased more than five-fold since 2004 to almost 7 per 1,000 hospital births. Little is known about the long-term effects of this condition, and there are few standard, evidence-based treatments for NOWS.

About the Program

Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW) aims to inform the clinical care of infants who are exposed to opioids in the womb.

In 2017, ACT NOW pilot studies assessed the variation in care for NOWS across 30 research hospitals. Researchers also surveyed current management approaches to prepare for developing research protocols for large-scale studies.

In this phase of the project, ACT NOW clinical trials will provide an evidence base for the clinical care of infants with NOWS to help inform medical practice and health policy.

  • The ACT NOW Eat, Sleep, Console (ESC) Clinical Trial will receive additional funding. ESC is a strategy to treat infants with NOWS without using drugs.
  • The ACT NOW Trial to Shorten Pharmacologic Treatment of Newborns with NOWS (Weaning Trial) will receive additional funding to compare rapid with slow opioid weaning among neonates with NOWS treated with morphine or methadone.
  • The ACT NOW Longitudinal Study will address knowledge gaps about the impact of antenatal opioid exposure and NOWS on childhood brain structure and connectivity and on medical, developmental, and behavioral trajectories in early childhood. The study will also identify risk factors for adverse sequelae to optimize neurodevelopmental, behavioral, and family outcomes.

Program Details

Through the Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM, NIH has funded RTI International to support the ACT NOW Longitudinal Study. The study will establish a research consortium using the infrastructure and longstanding collaborations of four of the clinical sites with the highest enrollments and the data coordinating center of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network (NRN).

Trial sites will be selected from the NRN and Institutional Development Award (IDeA) States Pediatric Clinical Trials Network sites.

Research Examples

ACT NOW ESC Clinical Trial

The ESC Clinical Trial is evaluating a novel approach to assess and care for infants with NOWS without using opioids.

ACT NOW Weaning Trial

The Weaning Trial is evaluating how quickly infants with NOWS who need pharmacological therapy can be weaned from opioids.

ACT NOW Longitudinal study

The ACT NOW Longitudinal Study will use neuroimaging measures to better understand the effects of prenatal opioid exposure and NOWS on brain structure and connectivity as well as how maternal and environmental factors interact with antenatal opioid exposure to influence the trajectories of connectivity, development, and behavior.

Linked Center Core Grant 

  • RTI International – North Carolina

Supplements 

  • Duke University – North Carolina
  • RTI International – North Carolina

Funded Projects

2019
HEAL Initiative: Antenatal Opioid Exposure Longitudinal Study Consortium
Sep 25, 2019
2019
ACT NOW Clinical Trials: ESC and Weaning Protocols
Sep 25, 2019
2019
MFMU Network Administrative Supplement
Sep 25, 2019