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

Leslie W Young; Songthip T Ounpraseuth; Stephanie L Merhar; Zhuopei Hu; Alan E Simon; Andrew A Bremer; Jeannette Y Lee; Abhik Das; Margaret M Crawford; Rachel G Greenberg; P Brian Smith; Brenda B Poindexter; Rosemary D Higgins; Michele C Walsh; Ward Rice; David A Paul; Jessie R Maxwell; Sucheta Telang; Camille M Fung; Tanner Wright; Anne Marie Reynolds; Devon W Hahn; Julie Ross; Jennifer M McAllister; Moira Crowley; Sophie K Shaikh; Karen M Puopolo; Lori Christ; Jaime Brown; Julie Riccio; Kara Wong Ramsey; Akshatha; Erica F Braswell; Lauren Tucker; Karen R McAlmon; Krishna Dummula; Julie Weiner; Jessica R White; Meghan P Howell; Sarah Newman; Jessica N Snowden; Lori A Devlin; ACT NOW Collaborative

doi:10.1056/NEJMoa2214470

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

N Engl J Med. 2023 Jun 22;388(25):2326-2337. doi: 10.1056/NEJMoa2214470. Epub 2023 Apr 30.

Authors

Leslie W Young¹, Songthip T Ounpraseuth¹, Stephanie L Merhar¹, Zhuopei Hu¹, Alan E Simon¹, Andrew A Bremer¹, Jeannette Y Lee¹, Abhik Das¹, Margaret M Crawford¹, Rachel G Greenberg¹, P Brian Smith¹, Brenda B Poindexter¹, Rosemary D Higgins¹, Michele C Walsh¹, Ward Rice¹, David A Paul¹, Jessie R Maxwell¹, Sucheta Telang¹, Camille M Fung¹, Tanner Wright¹, Anne Marie Reynolds¹, Devon W Hahn¹, Julie Ross¹, Jennifer M McAllister¹, Moira Crowley¹, Sophie K Shaikh¹, Karen M Puopolo¹, Lori Christ¹, Jaime Brown¹, Julie Riccio¹, Kara Wong Ramsey¹, Akshatha¹, Erica F Braswell¹, Lauren Tucker¹, Karen R McAlmon¹, Krishna Dummula¹, Julie Weiner¹, Jessica R White¹, Meghan P Howell¹, Sarah Newman¹, Jessica N Snowden¹, Lori A Devlin¹; ACT NOW Collaborative

Collaborators

ACT NOW Collaborative:
Akshatha Akshatha, Erica F Braswell, Andrew A Bremer, Jaime Brown, Lori Christ, Margaret M Crawford, Moira Crowley, Abhik Das PhD, Lori A Devlin, Krishna Dummula, Camille M Fung, Rachel G Greenberg, Devon W Hahn, Rosemary D Higgins, Meghan P Howell, Zhuopei Hu Ms, Jeannette Y Lee, Jessie R Maxwell, Jennifer M McAllister, Karen R McAlmon, Stephanie L Merhar, Sarah Newman, Songthip Ounpraseuth, David A Paul, Brenda B Poindexter, Karen M Puopolo, Anne Marie Reynolds, Julie Riccio, Ward Rice, Julie Ross, Sophie K Shaikh, Alan E Simon, P Brian Smith, Jessica N Snowden, Sucheta Telang, Lauren Tucker, Michele C Walsh, Julie Weiner, Jessica R White, Kara Wong Ramsey, Tanner Wright, Leslie W Young

Affiliation

¹ From the Larner College of Medicine, University of Vermont, Burlington (L.W.Y.); the Departments of Biostatistics (S.T.O., Z.H., J.Y.L.) and Pediatrics (J.N.S.), University of Arkansas for Medical Sciences, Little Rock; the University of Cincinnati College of Medicine and Perinatal Institute and the Division of Neonatology, Cincinnati Children's Hospital Medical Center, Cincinnati (S.L.M., W.R., J.M.M.), the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland (M.C.), and the Department of Pediatrics, Nationwide Children's Hospital, Ohio State University College of Medicine, Columbus (E.F.B.); the Institutional Development Awards Program of the States Pediatric Clinical Trials Network, Environmental Influences on Child Health Outcomes (ECHO) Program, National Institutes of Health, Rockville (A.E.S.), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda (A.A.B., R.D.H., M.C.W.) - both in Maryland; the Social, Statistical, and Environmental Sciences Unit, RTI International, Research Triangle Park (A.D., M.M.C.), and the Duke Clinical Research Institute, Duke University School of Medicine (R.G.G., P.B.S.), and the Department of Pediatrics, Duke University (S.K.S.), Durham - all in North Carolina; Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta (B.B.P.); the Office of Research and Sponsored Programs, Florida Gulf Coast University, Fort Myers (R.D.H.), and the Department of Pediatrics, University of South Florida, Tampa (T.W.); St. Elizabeth Healthcare, Edgewood (W.R.), and the Department of Pediatrics, University of Louisville, Louisville (S.T., L.A.D.) - both in Kentucky; the Division of Neonatology, Department of Pediatrics, ChristianaCare, Newark, DE (D.A.P.); the University of New Mexico School of Medicine, Albuquerque (J.R.M.); the Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City (C.M.F.); the Department of Pediatrics, University at Buffalo, Buffalo (A.M.R.), and the University of Rochester School of Medicine and Dentistry, Rochester (J. Riccio) - both in New York; the Oklahoma University Health Sciences Center, Oklahoma City (D.W.H.); the Medical University of South Carolina, Health Shawn Jenkins Children's Hospital, Charleston (J. Ross), and the Department of Pediatrics, Spartanburg Regional Medical Center, Spartanburg (J.B.) - both in South Carolina; the Section on Newborn Medicine, Pennsylvania Hospital (K.M.P.), and the Hospital of the University of Pennsylvania (L.C.), Philadelphia; the Kapiolani Medical Center for Women and Children, Honolulu (K.W.R., A.); the Department of Pediatrics, University of Mississippi Medical Center, Jackson (L.T.); Winchester Hospital, Winchester, MA (K.R.M.); the Department of Pediatrics, University of Kansas Medical Center (K.D.), and Children's Mercy Hospital (J.W.) - both in Kansas City, MO; Sanford Health, Sioux Falls, SD (J.R.W.); Tulane University School of Medicine, New Orleans (M.P.H.); and the University of Nebraska Medical Center, Omaha (S.N.).

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.).

Publication types

Comparative Study
Multicenter Study
Randomized Controlled Trial

MeSH terms

Analgesics, Opioid / adverse effects
Analgesics, Opioid / therapeutic use
Eating
Humans
Infant, Newborn
Narcotics / therapeutic use
Neonatal Abstinence Syndrome* / therapy
Patient Comfort
Severity of Illness Index
Sleep
Substance Withdrawal Syndrome* / diagnosis
Substance Withdrawal Syndrome* / drug therapy
Substance Withdrawal Syndrome* / therapy
Time Factors
United States

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

Authors

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Affiliation

Abstract

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