Infants who are starting life with an opioid addiction may benefit from a hands-on care approach that was tested at Cincinnati Children’s and other centers. The “Eat, Sleep, Console” (ESC) care approach is more effective than usual care approaches for treating opioid-exposed infants, according to multi-center study results announced April 30, 2023, at the Pediatric Academic Societies annual meeting.

Opioid-exposed newborns can develop symptoms of neonatal opioid withdrawal syndrome (NOWS), which includes tremors, excessive crying and irritability, and problems with sleeping and feeding. ESC determines withdrawal severity based on how well an infant can eat, sleep and be consoled. The focus is on nonpharmacologic care, including increased family presence, holding, swaddling and rocking in low-stimulus environments, as first-line treatment.

The study, involving more than 1,300 newborns treated at 26 hospitals across the US, found that newborns cared for with ESC were discharged approximately 6.7 days earlier and were 63% less likely to receive drug therapy, compared to newborns cared for under the more commonly used Finnegan Neonatal Abstinence Scoring Tool (FNAST) approach. Safety outcomes at 3 months of age were similar between both groups.

The findings have been published in The New England Journal of Medicine, with Cincinnati Children’s neonatologist Stephanie Merhar, MD, MS, among the leading co-authors. Three Cincinnati Children’s Perinatal Institute partner hospitals also participated: the University of Cincinnati Medical Center neonatal intensive care unit (NICU), TriHealth’s Good Samaritan Hospital NICU, and the St. Elizabeth Healthcare NICU. Together, these hospitals provided the largest number of study enrollees.

Promising Results for Opioid-Exposed Newborns

The study showed that treating opioid-exposed newborns in neonatal intensive care units with this approach reduced their hospital lengths of stay from an average of 14.9 days to an average of 8.2 days. In addition, only 19.5% in the ESC group needed medications to treat opioid withdrawal compared to 52% among infants treated according to guidelines set by NFAST.

Hospitals have widely different approaches for caring for these babies. They often use NFAST to assess newborns with NOWS. NFAST assesses signs of withdrawal in more than 20 areas, but some are concerned about the scoring system’s subjectivity and feel the need for opioid medication is being overestimated. ESC could help reduce the use of opioids in treating NOWS if future results are similar.

“Ohio and Kentucky have been hit hard by the opioid epidemic,” says Merhar, who oversaw the regional participation in the study. “Understanding ways to improve the outcomes of babies and families affected by opioids is of particular importance to us, and ESC will help many babies in our region.”

The ESC care approach was developed about eight years ago, but before this trial, it hadn’t been rigorously evaluated in a large and diverse population of infants with NOWS. A two-year follow-up study of a subset of the infants is ongoing. Merhar and Jennifer Vannest, PhD, CCC-SLP, also have received an $8 million research grant to further study the longer-term impacts of preterm opioid exposure.

Cincinnati Children’s is part of the Eunice Kennedy Shriver National Institute for Child and Human Development (NICHD) Neonatal Research Network (NRN), which partnered with the Institutional Developmental Awards (IDeA) Program States Pediatric Clinical Trials Network to conduct this large study. Our Perinatal Institute was one of the most active centers in the trial, funded by the National Institute of Health’s Helping to End Addiction Long-term Initiative (NIH HEAL)—a trans-agency effort to speed scientific solutions to stem the national opioid crisis. The trial was coordinated by the Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW) Collaborative and is a joint effort between the NICHD and the NIH Environmental influences on Child Health Outcomes (ECHO) Program.