ACT NOW

ECHO ACT NOW Current Experience Manuscript Published in Pediatrics

Posted on by Jodi Snare

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 syndrome (NOWS). The data collected were used to inform two of the ACT NOW clinical trials which are currently enrolling and will shape policies, programs, and practices in the care of infants with NOWS.

This cross-sectional study of 1,377 infants with evidence of opioid exposure at 30 participating hospitals nationwide described variation in maternal-infant characteristics, infant management, and outcomes for infants with NOWS.

The study found that sites varied widely in the proportion of infants whose mothers received adequate prenatal care, medication-assisted treatment, and prenatal counseling. Sites also varied in the proportion of infants with toxicology screening and proportion of infants receiving pharmacologic therapy, secondary medications, and non-pharmacologic interventions, including fortified feeds and maternal breast milk. The mean length of stay varied across sites (from two to 29 days), as did the proportion of infants discharged with their parents.

The study concluded that the wide variation in characteristics and treatment makes it unlikely that all infants are receiving efficient and effective care for NOWS. The research suggests that this variation should be considered in future clinical trial development, practice implementation, and policy development.

“Understanding the current landscape of NOWS is critical for future research and the development of programs, policies, and practices to provide better care for these infants,” said Leslie Young, MD, of the University of Vermont. “The degree of variation among infants with NOWS observed in this study shows a significant opportunity to improve the care they receive.”

Also available is a commentary associated with the article, emphasizing the importance of ISPCTN’s work for the field.

Establishing a Standard of Care for Babies Born Dependent on Opioids

Posted on by Jodi Snare

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.