The Child Health Research Institute is a site in the Eating, Sleeping and Consoling for Neonatal Opioid Withdrawal (ESC-NOW) study, a nationwide clinical trial funded by the National Institutes of Health.
CHRI Executive Director Ann Anderson Berry, MD, PhD, vice chair of research for the UNMC Department of Pediatrics and the Dr. John and Patti Sparks Chair of Pediatric Research at UNMC, serves as the primary investigator for the local study site. Sarah Newman, DNP, nurse practitioner with Nebraska Medicine, works on the study’s national writing team.
CHRI, a partnership of UNMC and Children’s Hospital & Medical Center, is one of 26 sites participating in the study, which found that the “Eat, Sleep, Console” care approach (ESC) is more effective than usual care approaches for opioid-exposed infants.
Researchers found the ESC approach substantially decreased the time until 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, compared to newborns cared for under the usual approach using traditional scoring methods. Safety outcomes at three months of age were similar between both groups. The study appears in the New England Journal of Medicine.
The ESC-NOW study is a collaborative effort between NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development and the NIH Environmental influences on Child Health Outcomes 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.
CHRI’s participation in the study was made possible through the Nebraska Pediatric Clinical Trial Unit, led by Russell McCulloh, MD, UNMC’s associate vice chancellor for clinical research.
Opioid-exposed newborns can develop symptoms of neonatal opioid withdrawal syndrome. Symptoms can include tremors, excessive crying and irritability and problems with sleeping and feeding.
Hospitals have widely different approaches for caring for these babies. They often use the Finnegan Neonatal Abstinence Scoring Tool, or FNAST, to assess newborns with neonatal opioid withdrawal syndrome. 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.
Until now, there hasn’t been strong evidence to support a standard of care for these babies. Having evidence for best practices, or a standard approach, to care for these infants can reduce variability and thus improve outcomes for these infants and their families. The goal of this trial was to help establish that evidence base.
The ESC care approach was developed about eight years ago but before this trial hadn’t yet been rigorously evaluated in a large and diverse population of infants with neonatal opioid withdrawal syndrome. 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.
ESC empowers families in the care of their infants through education and shared decision making, which can build trust and help families feel valued and supported.
To examine the extent to which ESC might be an optimal care approach for babies with neonatal opioid withdrawal syndrome, researchers in this study enrolled 1,305 infants across 26 U.S. hospitals, including CHRI. 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.
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, and 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.
The IRB protocol number for the study is IRB#0934-19-CB.
What fantastic results! Congratulations to Dr. Anderson Berry, Sarah Newman and the entire team involved with this project. This should make a huge difference in the lives of so many babies and families.
What an important study for these babies and their families. You all are amazing!