Eat, Sleep, Console Approach or Usual Care for Neonatal Opioid Withdrawal.

Document Type

Article

Publication Date

6-22-2023

Identifier

DOI: 10.1056/NEJMoa2214470

Abstract

BACKGROUND: Although clinicians have traditionally used the Finnegan Neonatal Abstinence Scoring Tool to assess the severity of neonatal opioid withdrawal, a newer function-based approach - the Eat, Sleep, Console care approach - is increasing in use. Whether the new approach can safely reduce the time until infants are medically ready for discharge when it is applied broadly across diverse sites is unknown.

METHODS: In this cluster-randomized, controlled trial at 26 U.S. hospitals, we enrolled infants with neonatal opioid withdrawal syndrome who had been born at 36 weeks' gestation or more. At a randomly assigned time, hospitals transitioned from usual care that used the Finnegan tool to the Eat, Sleep, Console approach. During a 3-month transition period, staff members at each hospital were trained to use the new approach. The primary outcome was the time from birth until medical readiness for discharge as defined by the trial. Composite safety outcomes that were assessed during the first 3 months of postnatal age included in-hospital safety, unscheduled health care visits, and nonaccidental trauma or death.

RESULTS: A total of 1305 infants were enrolled. In an intention-to-treat analysis that included 837 infants who met the trial definition for medical readiness for discharge, the number of days from birth until readiness for hospital discharge was 8.2 in the Eat, Sleep, Console group and 14.9 in the usual-care group (adjusted mean difference, 6.7 days; 95% confidence interval [CI], 4.7 to 8.8), for a rate ratio of 0.55 (95% CI, 0.46 to 0.65; P < 0.001). The incidence of adverse outcomes was similar in the two groups.

CONCLUSIONS: As compared with usual care, use of the Eat, Sleep, Console care approach significantly decreased the number of days until infants with neonatal opioid withdrawal syndrome were medically ready for discharge, without increasing specified adverse outcomes. (Funded by the Helping End Addiction Long-term (HEAL) Initiative of the National Institutes of Health; ESC-NOW ClinicalTrials.gov number, NCT04057820.).

Journal Title

The New England journal of medicine

Volume

388

Issue

25

First Page

2326

Last Page

2337

MeSH Keywords

Humans; Infant, Newborn; Analgesics, Opioid; Narcotics; Neonatal Abstinence Syndrome; Sleep; Substance Withdrawal Syndrome; Eating; United States; Severity of Illness Index; Time Factors; Patient Comfort

Keywords

Opioid Analgesics; Narcotics; Neonatal Abstinence Syndrome; Sleep; Substance Withdrawal Syndrome; Eating; United States; Severity of Illness Index; Time Factors; Patient Comfort

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