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RTI researchers contribute to key findings published in the New England Journal of Medicine
RESEARCH TRIANGLE PARK, N.C. — The “Eat, Sleep, Console” care approach (ESC) is more effective than usual care approaches for treating opioid-exposed infants, according to researchers from nonprofit research institute RTI International, one of the data coordinating centers for a nationwide clinical trial funded by the National Institutes of Health (NIH).
The ESC care approach substantially decreased the time until opioid-exposed infants were medically ready for discharge. Newborns cared for with ESC were medically ready for discharge approximately 6.7 days earlier and were 63% less likely to receive drug therapy for neonatal opioid withdrawal syndrome (NOWS), compared to newborns cared for using traditional scoring methods. Safety outcomes at three months of age were similar between both groups. The current findings are published in the New England Journal of Medicine.
“It is wonderful that we saw such a substantial reduction in both time to medical readiness for discharge as well as in the proportion of infants needing opioids therapy for NOWS,” said author Abhik Das, Ph.D., RTI Distinguished Fellow, biostatistics. “We look forward to the follow-up phase to ensure long term safety of the ESC approach.”
Opioid-exposed newborns can develop symptoms of withdrawal, which includes tremors, excessive crying and irritability and problems with sleeping and feeding.
The ESC care approach was developed about eight years ago, but it had not been rigorously evaluated in a large and diverse population of infants with NOWS before this trial. ESC provides a function-based assessment of withdrawal severity centered around how well an infant can eat, sleep and be consoled. ESC prioritizes nonpharmacologic care, including increased family presence, holding, swaddling and rocking in low-stimulus environments, as first line treatment.
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. Infants cared for with ESC were medically ready for discharge after an average of 8.2 days, whereas infants cared for with Finnegan Neonatal Abstinence Scoring Tool (FNAST) were medically ready for discharge after 14.9 days.
The study also evaluated whether newborns received opioid therapy to manage their symptoms. Infants cared for with ESC were about 63% less likely to receive opioids (19.5% in the ESC group received opioid therapy, compared to 52% in the FNAST group).
These findings are based on three-month outcomes. A two-year follow-up study of a subset of the infants is ongoing. This follow-up is critical to further inform the safety of the ESC care approach.
“This was a complex trial involving a stepped wedge cluster randomized design with extensive site training and collaboration,” said author Meg Crawford, RTI manager, clinical studies. “We hope our study results will lead to safer and more effective treatments for this very vulnerable population of babies.”
The trial is a collaborative effort between the NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network (NRN) and the NIH Environmental influences on Child Health Outcomes (ECHO) Program IDEA States Pediatric Clinical Trials Network.
RTI serves as Data Coordinating Center for the NRN, providing biostatistical leadership, data management and logistical coordination and support for all NRN studies, including the ESC trial. This trial is funded by the Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative®—a trans-agency federal effort to speed scientific solutions to stem the national opioid crisis.
