KU Medical Center researcher among authors of study published in NEJM identifying a more effective way to care for opioid-exposed newborns
The “Eat, Sleep, Console” care approach was more effective than standard of care to treat newborns exposed to opioids in the womb, according to a national clinical trial in which KU Medical Center participated.
Every 18 minutes, a newborn baby in the United States is diagnosed with neonatal opioid withdrawal syndrome (NOWS). Born to mothers with an addiction to opioids that is passed through the placenta, these infants can have tremors, excessive crying and irritability, along with problems sleeping and feeding. They are typically treated pharmacologically with opioids, from which they are then weaned over a matter of days to weeks depending on the severity of their withdrawal symptoms.
A clinical trial published in the New England Journal of Medicine has confirmed that there is a more effective treatment: the “Eat, Sleep, Console” approach (ESC), which engages the mother and other caregivers in managing the NOWS symptoms by caring for and comforting the baby. The trial was funded by the Helping to End Addiction Long-term Initiative, a National Institutes of Health program.
“This approach is just as the name says,” said Krishna Dummula, M.D., MPH, one of the authors of the study and an associate professor of pediatrics at the University of Kansas Medical Center, a participating site in the trial. “The primary focus is on promoting nonpharmacologic approaches and trying to make sure that the baby sleeps and eats often, while also holding and swaddling the baby to comfort them.”
To examine the extent to which ESC might be an optimal care approach for babies with NOWS, researchers in this study enrolled 1,305 infants across 26 U.S. hospitals, including The University of Kansas Health System, the clinical partner of the University of Kansas Medical Center.
Shortened hospital stay, reduced need for drug therapy
Hospitals have widely different approaches to caring for these babies. They often use the Finnegan Neonatal Abstinence Scoring Tool (FNAST), which assesses signs of withdrawal in more than 20 areas, to diagnose newborns with NOWS and determine if they need drug therapy. Concerns have been raised about its subjectivity and overestimation of the need for opioid medication.
The ESC care approach was developed about eight years ago, but before this trial it hadn’t yet been rigorously evaluated in a large and diverse population of infants with NOWS. ESC provides a function-based assessment of withdrawal severity, rather than a scoring system, centered around how well an infant can eat, sleep and be consoled.
The trial showed that the ESC care approach substantially decreased the time until infants were medically ready for discharge after an average of 8.2 days, which was 6.7 days earlier than the babies treated with the FNAST approach. They were also 63% less likely to eventually need and receive drug therapy (19.5% in the ESC group received opioid therapy, compared to 52% in the FNAST group). Safety outcomes at three months of age were similar between both groups.
“Aside from enhancing parent-infant bonding and reducing the hospital stay, the ESC approach may result in an estimated nationwide health care cost savings of about a quarter of a billion dollars (based on 2014 data),” noted Dummula, who was the principal investigator for the KU Medical Center site.
The trial launched in 2020, which meant that nursing staff at The University of Kansas Health System were trained to transition from the conventional NOWS approach to the ESC method when the COVID-19 pandemic was in full swing. “It really was a herculean effort by all, and having these positive study results is so exciting, validating the efforts of so many,” said Kristina Foster, APRN-BC, the primary site coordinator at KU Medical Center.
These findings are based on three-month outcomes. A two-year follow-up study of a subset of the infants is ongoing, which is necessary to further inform the safety of the ESC care approach.
“Finnegan was a very subjective evaluation, so there was some chance that we were starting opioids on more babies than was needed,” said Dummula. “So now that we are showing more restraint by going to nonpharmacologic approaches, we have been essentially able to reduce the number of babies that receive post-natal drug therapy.”
KU Medical Center’s participation in the trial was facilitated by The Environmental Influences on Child Health Outcomes IDeA States Pediatric Clinical Trials Network (ECHO ISPCTN) through the Sunflower Pediatric Clinical Trials grant.