Randomized Controlled Trial

. 2023 Jun 22;388(25):2326-2337.

doi: 10.1056/NEJMoa2214470. Epub 2023 Apr 30.

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

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, Affiliations

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.).

PMID: 37125831
PMCID: PMC10433732
DOI: 10.1056/NEJMoa2214470

Randomized Controlled Trial

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

Leslie W Young et al. N Engl J Med. 2023.

. 2023 Jun 22;388(25):2326-2337.

doi: 10.1056/NEJMoa2214470. Epub 2023 Apr 30.

Authors

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.).

PMID: 37125831
PMCID: PMC10433732
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.).

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Figures

**Figure 1.. Process for Site Training and Implementation of the Eat, Sleep, Console Approach.**
During the first trial period, all the infants with opioid withdrawal were cared for according to the usual-care practices at each site. At a randomly assigned time, each site entered a 3-month transition period, which included training and implementation activities at the site. After this transition, the infants with opioid withdrawal were cared for according to the Eat, Sleep, Console approach along with its care tool. Details regarding the intervention and the processes for training and implementation are provided in Figures S2 through S4 in the Supplementary Appendix.

**Figure 2.. Enrollment, Randomization, and Analytic Sample.**
Details regarding eligibility criteria for participation in the trial are provided in Table S1 in the Supplementary Appendix.

See this image and copyright information in PMC

Comment in

Hush Little Baby - Promise of the Eat, Sleep, Console Approach.
Barfield WD. Barfield WD. N Engl J Med. 2023 Jun 22;388(25):2391-2392. doi: 10.1056/NEJMe2304989. N Engl J Med. 2023. PMID: 37342927 No abstract available.

References

1. Agency for Healthcare Research and Quality. HCUP Fast Stats. May 2022. (https://hcup-us.ahrq.gov/faststats/landing.jsp).
1. Finnegan LP, Connaughton JF Jr, Kron RE, Emich JP. Neonatal abstinence syndrome: assessment and management. Addict Dis 1975;2:141–58. - PubMed
1. Young LW, Hu Z, Annett RD, et al. Site-level variation in the characteristics and care of infants with neonatal opioid withdrawal. Pediatrics 2021;1 47(1):e2020008839. - PMC - PubMed
1. Finnegan LP, Kron RE, Connaughton JF, Emich JP. Assessment and treatment of abstinence in the infant of the drug-dependent mother. Int J Clin Pharmacol Biopharm 1975;12:19–32. - PubMed
1. Gomez Pomar E, Finnegan LP, Devlin L, et al. Simplification of the Finnegan neonatal abstinence scoring system: retrospective study of two institutions in the USA. BMJ Open 2017;7(9):e016176. - PMC - PubMed

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

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

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