ECHO ISPCTN Current Studies

Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW)

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 babies have in utero exposure to opioids, they 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 Research Studies

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).

Study Status: Closed to enrollment; follow up of infants to 2-years of age will be completed in 2026.

SPeCTr is participating in/has participated in all three of the ACT NOW studies.

Talk With Me Baby

Jr Investigator Pilot

The goal of this clinical trial is to learn if the Talk With Me Baby (TWMB) program improves the home-language environment for families with infants ages two to six months when primary care providers deliver the program during well-child checkups. The main question it aims to answer is:

Will the TWMB program increase the time a caregiver talks to their infant?

Participants will:

Come to at least four well-child checkups
Receive the TWMB program from the provider during the checkups
Record their conversations with their infant before they receive the program and after they receive the program four times.

NCT 06479278