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

Authors

Leslie W. Young, Larner College of Medicine, University of Vermont, Burlington
Songthip T. Ounpraseuth, Larner College of Medicine, University of Vermont, Burlington; Departments of Biostatistics
Stephanie L. Merhar, Larner College of Medicine, University of Vermont, Burlington; 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
Zhuopei Hu, Larner College of Medicine, University of Vermont, Burlington; Departments of Biostatistics
Alan E. Simon, Larner College of Medicine, University of Vermont, Burlington; Institutional Development Awards Program of the States Pediatric Clinical Trials Network, Environmental Influences on Child Health Outcomes (ECHO) Program, National Institutes of Health, Rockville
Andrew A. Bremer, Larner College of Medicine, University of Vermont, Burlington; Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda
Jeannette Y. Lee, Larner College of Medicine, University of Vermont, Burlington; Departments of Biostatistics
Abhik Das, Larner College of Medicine, University of Vermont, Burlington; he Social, Statistical, and Environmental Sciences Unit, RTI International, Research Triangle Park
Margaret M. Crawford, Larner College of Medicine, University of Vermont, Burlington; he Social, Statistical, and Environmental Sciences Unit, RTI International, Research Triangle Park
Rachel G. Greenberg, Larner College of Medicine, University of Vermont, Burlington; Duke Clinical Research Institute, Duke University School of Medicine
P Brian Smith, Larner College of Medicine, University of Vermont, Burlington; Duke Clinical Research Institute, Duke University School of Medicine
Brenda B. Poindexter, Larner College of Medicine, University of Vermont, Burlington; Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta
Rosemary D. Higgins, Larner College of Medicine, University of Vermont, Burlington; Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda; Office of Research and Sponsored Programs, Florida Gulf Coast University, Fort Myers
Michele C. Walsh, Larner College of Medicine, University of Vermont, Burlington; Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda
Ward Rice, Larner College of Medicine, University of Vermont, Burlington; 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; St. Elizabeth Healthcare, Edgewood
David A. Paul, Larner College of Medicine, University of Vermont, Burlington; Division of Neonatology, Department of Pediatrics, ChristianaCare, Newark, DE
Jessie R. Maxwell, Larner College of Medicine, University of Vermont, Burlington; University of New Mexico School of Medicine, Albuquerque
Sucheta Telang, Larner College of Medicine, University of Vermont, Burlington; Department of Pediatrics, University of Louisville, Louisville
Camille M. Fung, Larner College of Medicine, University of Vermont, Burlington; Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City
Tanner Wright, Larner College of Medicine, University of Vermont, Burlington; Department of Pediatrics, University of South Florida, Tampa
Anne Marie Reynolds, Larner College of Medicine, University of Vermont, Burlington; Department of Pediatrics, University at Buffalo, Buffalo
Devon W. Hahn, Larner College of Medicine, University of Vermont, Burlington; Oklahoma University Health Sciences Center, Oklahoma City
Julie Ross, Larner College of Medicine, University of Vermont, Burlington; Medical University of South Carolina, Health Shawn Jenkins Children's Hospital, Charleston
Jennifer M. McAllister, Larner College of Medicine, University of Vermont, Burlington; 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
Moira Crowley, Larner College of Medicine, University of Vermont, Burlington; the Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland
Sophie K. Shaikh, Larner College of Medicine, University of Vermont, Burlington; Department of Pediatrics, Duke University
Karen M. Puopolo, Larner College of Medicine, University of Vermont, Burlington; Section on Newborn Medicine, Pennsylvania Hospital
Lori Christ, Larner College of Medicine, University of Vermont, Burlington; Hospital of the University of Pennsylvania
Jaime Brown, Larner College of Medicine, University of Vermont, Burlington; Department of Pediatrics, Spartanburg Regional Medical Center, Spartanburg
Julie Riccio, Larner College of Medicine, University of Vermont, Burlington; University of Rochester School of Medicine and Dentistry, Rochester
Kara Wong Ramsey, Larner College of Medicine, University of Vermont, Burlington; Kapiolani Medical Center for Women and Children, Honolulu
Akshatha Akshatha, Larner College of Medicine, University of Vermont, Burlington; Kapiolani Medical Center for Women and Children, Honolulu
Erica F. Braswell, Larner College of Medicine, University of Vermont, Burlington; Department of Pediatrics, Nationwide Children's Hospital, Ohio State University College of Medicine, Columbus
Lauren Tucker, Larner College of Medicine, University of Vermont, Burlington; Department of Pediatrics, University of Mississippi Medical Center, Jackson
Karen R. McAlmon, Larner College of Medicine, University of Vermont, Burlington; Winchester Hospital, Winchester, MA
Krishna Dummula, Larner College of Medicine, University of Vermont, Burlington; Department of Pediatrics, University of Kansas Medical Center
Julie Weiner, Larner College of Medicine, University of Vermont, Burlington; Children's Mercy Hospital
Jessica R. White, Larner College of Medicine, University of Vermont, Burlington; Sanford Health, Sioux Falls, SD
Meghan P. Howell, Larner College of Medicine, University of Vermont, Burlington; Tulane University School of Medicine, New Orleans
Sarah Newman, Larner College of Medicine, University of Vermont, Burlington; University of Nebraska Medical Center, Omaha
Jessica N. Snowden, Larner College of Medicine, University of Vermont, Burlington; Departments of Pediatrics
Lori A. Devlin, Larner College of Medicine, University of Vermont, Burlington; Department of Pediatrics, University of Louisville, Louisville
ACT NOW Collaborative

Document Type

Article

Publication Date

6-22-2023

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

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.).

Publisher

Massachusetts Medical Society.

Publication Title

The New England journal of medicine

ISSN

1533-4406

Volume

388

Issue

25

First Page

2326

Last Page

2337

DOI

10.1056/NEJMoa2214470

Recommended Citation

Young LW, Ounpraseuth ST, Merhar SL, Hu Z, Simon AE, Bremer AA, Lee JY, Das A, Crawford MM, Greenberg RG, Smith PB, Poindexter BB, Higgins RD, Walsh MC, Rice W, Paul DA, Maxwell JR, Telang S, Fung CM, Wright T, Reynolds AM, Hahn DW, Ross J, McAllister JM, Crowley M, Shaikh SK, Puopolo KM, Christ L, Brown J, Riccio J, Wong Ramsey K, Akshatha, Braswell EF, Tucker L, McAlmon KR, Dummula K, Weiner J, White JR, Howell MP, Newman S, Snowden JN, Devlin LA; ACT NOW Collaborative. 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. PMID: 37125831.