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May 02, 2024
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‘Eat, sleep, console’ improves outcomes for opioid-affected neonates

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Key takeaways:

  • Neonatal opioid withdrawal syndrome is often assessed with the 50-year-old Finnegan scoring tool.
  • Researchers noticed better outcomes with the “East, Sleep, Console” approach.

The Eat, Sleep, Console approach — which prioritizes nonpharmacologic care — improved outcomes among infants treated for opioid withdrawal syndrome, according to study results published in JAMA Pediatrics.

For over 50 years, the severity of neonatal opioid withdrawal syndrome (NOWS) has been assessed with the Finnegan Neonatal Abstinence Scoring Tool, which the authors of the new study noted has been critiqued for its “subjectivity, lack of interrater reliability, and tendency to overestimate the need for pharmacologic treatment.”

IDC0424Devlin_Graphic_01

The Eat Sleep Console (ESC) approach was designed to focus on the “functional components of withdrawal,” such as whether an infant can eat, sleep and be consoled.

Trial development began 7 years ago in response to a lack of generalizable evidence to support the best approach to the assessment and management of infants with NOWS, according to one of the authors.

“The lack of strong evidence has led to substantial variation in care, and when we’re providing highly variable care, we’re not providing the best care,” Lori A. Devlin, DO, neonatologist with Norton Children's and professor of pediatrics at the University of Louisville, told Healio.

“In addition, medical teams have often not been well trained in how to decrease stigmatizing language when communicating with the families of infants with NOWS,” Devlin said. “Stigmatizing language may exacerbate past trauma and relegate families to bystanders as their infants are cared for in the hospital. You can imagine that this may lead to families becoming disengaged.”

Primary outcomes from the Eating, Sleeping and Consoling for Neonatal Opioid Withdrawal (ESC-NOW) trial conducted by Devlin and colleagues, which are published in the New England Journal of Medicine, showed that use of the approach significantly decreased the number of days until infants with NOWS were medically ready for discharge and the use of pharmacologic treatment compared with usual care with the Finnegan tool without increasing specified adverse outcomes.

The JAMA Pediatrics article reports the results of a subgroup analysis of pharmacologically treated infants enrolled in the ESC-NOW trial. Devlin said they wanted to take “a deeper dive and look specifically at the influence of the ESC care approach on infants who received opioid treatment for NOWS after birth.”

In the ESC-NOW trial, Devlin and colleagues enrolled 1,305 infants with NOWS from 26 U.S. hospitals. All infants were born at 36 weeks’ gestation or later and treated for NOWS at one of the participating study hospitals between September 2020 and March 2022.

The study was designed as a stepped-wedge cluster randomized controlled trial with a transition period. All study hospitals started the first study period using their usual approach to care for infants with NOWS, which included use of the Finnegan tool and then transitioned to the ESC care approach, per their randomized allocation. During the transition period, personnel at each site underwent extensive training to optimize consistency in the implementation and the use of the ESC care approach.

Of the 1,305 enrolled infants, 463 received pharmacologic treatment (23.7% in the ESC care approach group and 45.6% in the usual care group). For infants who received pharmacologic treatment, the mean total opioid exposure was lower in the ESC care approach group, with an absolute difference of 4.1 morphine milligram equivalents per kilogram (MME/kg; 95% CI, 1.3-7) compared with usual care (4.8 MME/kg vs. 8.9 MME/kg, respectively; P = .001).

Additionally, the mean length of treatment was 6.3 days shorter (95% CI, 3-9.6) in the ESC group compared with the usual care group at 11.8 vs. 18.1 days, and the mean length of stay was 6.2 days shorter (95% CI, 3-9.4) in the ESC group than in the usual care group (16.7 vs. 22.9 days, respectively; P < .001).

“Through the ESC-NOW trial, we have found that the ESC care approach markedly reduces the proportion of infants who receive pharmacologic treatment, and it substantially decreases total opioid exposure after birth for those infants who are pharmacologically treated when compared to usual care with the Finnegan tool,” Devlin said.

Devlin said building evidence to support a standard care approach for NOWS, “take(s) a bit of time.” The team is completing a 2-year neurodevelopmental follow-up study on a subgroup of infants enrolled in the ESC-NOW study this summer, and is working on several additional secondary analyses from the ESC-NOW trial.

“There's a lot of rich research coming. We are excited to be building strong evidence to support a standard of care for infants with NOWS,” Devlin said.

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