Newborn infant being cradled, two pediatric nurses

Eat, Sleep, Console

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

May 2, 2023 by Janet Essman Franz

The opioid crisis surged in recent years, and New England has been hit particularly hard. Infants exposed to opioids in the womb can develop neonatal opioid withdrawal syndrome (NOWS), with symptoms including tremors, stiff muscles, upset stomach, excessive crying, and problems with sleeping and feeding. Historically, treatment of these infants involves a nurse measuring a baby’s withdrawal symptoms — such as level of irritability, pitch of crying, fever, or tremors — and often providing opioid medications, including morphine and methadone, as part of their care. Many of these infants experience long hospital stays to help them manage their withdrawal symptoms. 

New research led by Leslie Young, M.D., associate professor of pediatrics at UVM’s Larner College of Medicine, demonstrates that the “Eat, Sleep, Console” care approach (ESC), which uses a function-based assessment of withdrawal severity and emphasizes parent involvement, skin-to-skin contact, breastfeeding, rocking, and a calm environment, is more effective than usual care approaches for treating infants exposed to opioids in the womb. The current findings are published in the New England Journal of Medicine.

The ESC-NOW trial, funded by the National Institutes of Health (NIH), examined the impact of the ESC care approach and found that it substantially decreased the time until infants were medically ready for discharge. Newborns cared for with ESC were medically ready for discharge 6.7 days earlier and were 63 percent less likely to receive medication, compared to newborns cared for under the usual care approach. 

 

Newborn baby rests with their parent

A healthy newborn rests with their parent at the University of Vermont Children’s Hospital. (Photo: Ryan Mercer)

“The data show that nonpharmacologic care with increased family presence, holding, swaddling, and a quiet, darkly lit room can improve outcomes for these infants,” said Young, a neonatologist at the University of Vermont Children’s Hospital and lead investigator for the study. “We know from our previous work that variation exists in how babies with opioid withdrawal are cared for at hospitals across the country. This is a wonderful opportunity to celebrate a new path forward, one that places value on the role of families in the care of their babies,” Young said. 

While the UVM Children’s Hospital did not enroll infants in this trial, it has used the ESC care approach for many years, and it was this local experience that informed the national study, according to Young. “I’m well into my second decade of caring for infants with opioid withdrawal and their families, and I have seen care evolve over time. The benefits of the ESC approach locally are undeniable,” she said. “As a clinician, I saw a clear opportunity to see if this approach could be applied more broadly.” 

Among the different approaches hospitals have used to care for babies with opioid withdrawal is the Finnegan Neonatal Abstinence Scoring Tool (FNAST). 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.

Unlike ESC, FNAST does not emphasize the families’ role in caring for their babies or reinforce nonpharmacologic care in a consistent way. ESC prioritizes nonpharmacologic care, including increased family presence, as first-line treatment.

“For many of the moms we work with, this is the first time that value has been placed on their role as a mother, which is huge, because they often have feelings of shame and guilt associated with what their baby is experiencing. To empower moms to care for their babies has resulted in an increase in parental presence, and babies do better,” Young said.

Before this trial, the ESC care approach had not been rigorously evaluated in a large and diverse population of infants with NOWS. 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 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 percent less likely to receive opioids (19.5 percent in the ESC group received opioid therapy, compared to 52 percent in the FNAST group). There was no difference in safety outcomes between the two groups. 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 trial is a collaborative effort between the NIH’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.

Dr. Leslie Young stands in the neonatal intensive care unit at the hospital
Leslie Young, M.D., uses the ESC care approach to care for infants at UVM Children's Hospital. It was this local experience that informed the national study. (Photo: Ryan Mercer)

“For many of the moms we work with, this is the first time that value has been placed on their role as a mother …  To empower moms to care for their babies has resulted in an increase in parental presence, and babies do better.”

— Leslie Young, M.D., associate professor of pediatrics