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 eat well, and poor sleep. Neonatal Opioid Withdrawal Syndrome, or NOWS, has increased five-fold over the last decade, but evidence as to the best approach for assessing and treating these infants is lacking.

That’s why ECHO—in partnership with the NIH Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)—is launching the Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) initiative. One intervention trial slated to begin in late summer 2020 is Eating, Sleeping, and Consoling for Neonatal Opioid Withdrawal (ESC-NOW). In this study, researchers will test the effectiveness of ESC, a new method that nurseries can adopt for assessing and treating infants with NOWS. Comparing ESC to the usual care NOWS babies receive, they’ll evaluate how the ESC approach affects the short term—being ready for discharge from the hospital–as well as longer-term: how this approach affects family and infant well-being, as well as how well the baby’s brain is developing, during the first 2 years of life.

The ESC approach engages parents and other primary caregivers in the treatment of NOWS. It emphasizes tactics like holding, swaddling, and rocking in low stimulus environments, thus potentially lowering the need for medication.

Up to 3,000 infants and their primary caregivers will be included in this clinical trial across 26 sites in the United States. By filling gaps in our knowledge of how to take care of these babies, the results of this study may very well set a standard for improving the care of infants with NOWS.

ESC-NOW is one of several ACT NOW studies funded through the National Institutes of Health Helping to End Addiction Long-term (HEAL) Initiative.