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New study identifies a more effective way to care for newborns exposed to opioids

Findings from the Eating, Sleeping and Consoling for Neonatal Opioid Withdrawal (ESC-NOW) study show a new care approach that is more effective than usual care approaches for opioid-exposed infants.

Eat, Sleep, Console promotes parental engagement and gives special attention to non-medication care methods like breastfeeding, swaddling, and skin-to-skin contact. The usual treatment for NOWS focuses on a nurse measuring the infant's withdrawal symptoms before providing medication treatment, such as methadone or morphine.

Researchers found that the ESC approach 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 nationwide clinical trial is a collaborative effort between 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.

Background on Neonatal Opioid Withdrawal Syndrome (NOWS)

The prevalence of opioid use disorder has increased in the U.S., which has also led to more pregnant women with opioid use disorder (OUD). As a result, more infants are being born with symptoms of opioid withdrawal. This condition is called neonatal opioid withdrawal syndrome (NOWS). NOWS symptoms can include tremors, excessive crying and irritability, and problems with sleeping and feeding.

Until now, there hasn’t been strong evidence to support a standard of care for babies with NOWS. Having evidence for best practices (or, a standard approach) to care for these infants can reduce variability and thus improve outcomes for infants and their families. The goal of this trial was to help establish that evidence base.

The ESC care approach

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 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.

Study results

Researchers in this study enrolled 1,305 infants across 26 U.S. hospitals. Infants cared for with ESC were medically ready for discharge nearly 7 days earlier than infants treated under usual care (8.2 days in the ESC group compared to 14.9 days in the usual care group).

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 usual care 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.

To access a summary of ESC in Spanish, click here.

HEAL Connections

The Addiction Policy Forum is a part of the HEAL Connections Center, created by the NIH HEAL Initiative® to translate HEAL research into action. The center’s goals are twofold: to create pathways to further build and sustain community partnerships, and to support HEAL researchers in meaningfully sharing results with communities and stakeholders that will benefit most from research findings. Learn more here.


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