New Clinical Trial Identifies a More Effective Way to Care for Newborns Exposed to Opioids in the Womb

Newborns exposed to opioids in the womb and their caregivers are benefiting from research currently underway at Oklahoma Children’s Hospital OU Health.

Called the “Eat, Sleep, Console” (ESC) care approach, Oklahoma Children’s Hospital is one of 26 sites participating in the nationwide clinical trial funded by the National Institutes of Health (NIH). The ESC care approach was developed eight years ago, but prior to the trial hadn’t been rigorously evaluated.

Opioid-exposed newborns can develop symptoms of neonatal opioid withdrawal syndrome, which includes tremors, excessive crying and irritability, as well as problems with sleeping and feeding. ESC provides a function-based assessment of withdrawal severity centered on how well an infant can eat, sleep, and be consoled and prioritizes care that does not include medication. Increased family presence, holding, swaddling, and rocking in low-stimulus environments are first-line treatments.

Historical approaches in caring for these babies included the use of the Finnegan Neonatal Abstinence Scoring Tool (FNAST) to assess newborns with NOWS. The FNAST is an extensive scoring system that assesses signs of withdrawal in more than 20 areas. Concerns have been raised about its subjectivity and overestimation of the need for opioid medication.

The newly published results show that the ESC care approach decreased the time infants were medically ready for discharge — by approximately 6.7 days and were 63% less likely to receive drug therapy, compared to newborns cared for under the usual approach using traditional scoring methods. These findings are based on three-month outcomes.

“This study not only validates the ESC care tool as an appropriate assessment for opioid exposed newborns, it also decreases the need for medication and gets them home sooner. It is improving the way we care for these babies,” said pediatrician Devon Hahn, M.D., who is leading the research effort at OU Health.

1,305 infants across 26 U.S. hospitals, including Oklahoma Children’s Hospital were enrolled in the study. Infants cared for with ESC were medically ready for discharge after an average of 8.2 days, whereas infants cared for with FNAST were medically ready for discharge after 14.9 days. Infants cared for with ESC were also about 63% less likely to receive opioids.

“Eat Sleep Console has helped us train our mother baby unit nurses, multi-disciplinary services and physician team to work collaboratively in the healthy unification of mother baby dyads,” said mother-baby unit medical director, neonatal hospitalist and pediatric clinical lead Benazir Drabu, M.D. “We have successfully kept narcotic-exposed newborns in ‘couplet care’ with their mothers as their champion caregivers, and this has been a game changer in managing these newborns.”

The current findings on the treatment approach for these infants has recently been published in the New England Journal of Medicine. The clinical trial is a collaborative effort between the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the NIH Environmental influences on Child Health Outcomes (ECHO) Program. The trial is funded by the Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative^®—a trans-agency effort to speed scientific solutions to stem the national opioid crisis.