Celebrating Clinical Trials

May 20 is Clinical Trials Day. This month, I’m pleased to be able to share important new findings from the ECHO IDeA States Pediatric Clinical Trials Network (ISPCTN), which helps address disparities in pediatric research by including children from rural or underserved populations in clinical trials, and by building pediatric research capacity in states with historically low NIH funding.

New ISPCTN research, titled “Eat, sleep, console approach versus usual care for neonatal opioid withdrawal,” was recently published in the New England Journal of Medicine. Researchers found that the “Eat, Sleep, Console” (ESC) care approach for treating newborns exposed to opioids during pregnancy substantially decreases the time until infants are medically ready for discharge and reduces use of opioid medications to treat these babies. Until now, there hasn’t been strong evidence to support a standard care approach for babies with neonatal opioid withdrawal syndrome (NOWS). Hospitals currently have widely different approaches. This clinical trial gives hospitals an evidence-based care approach for babies with NOWS. You can learn more about this study in the ECHO Connector Research Spotlight.

I’m also pleased to share that on March 16–17, 2023, ECHO hosted a virtual workshop on the Return of Individual Research Results to Participants to identify principles and best practices to ethically and feasibly return individual research results to participants in large-sample studies that include pregnant women and children. Over 500 registrants heard 16 expert speakers and discussants present their work on the history and principles of returning individual results, and the value of results to participants, in addition to a fruitful discussion on which results to return, and how to return individual results. More information and recordings of the presentations are available here.