Eat, Sleep, Console Approach or Usual Care for Neonatal Opioid Withdrawal.
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
22 Jun 2023
22 Jun 2023
Historique:
pmc-release:
22
12
2023
medline:
23
6
2023
pubmed:
1
5
2023
entrez:
1
5
2023
Statut:
ppublish
Résumé
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. 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. 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. 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.).
Sections du résumé
BACKGROUND
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
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
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
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.).
Identifiants
pubmed: 37125831
doi: 10.1056/NEJMoa2214470
pmc: PMC10433732
mid: NIHMS1907072
doi:
Substances chimiques
Analgesics, Opioid
0
Narcotics
0
Banques de données
ClinicalTrials.gov
['NCT04057820']
Types de publication
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
2326-2337Subventions
Organisme : NIH HHS
ID : U2C OD023375
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD087226
Pays : United States
Organisme : NICHD NIH HHS
ID : U01 HD036790
Pays : United States
Organisme : NIH HHS
ID : UG1 OD024943
Pays : United States
Organisme : NIH HHS
ID : UG1 OD024958
Pays : United States
Organisme : NIH HHS
ID : UG1 OD024942
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001117
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD053109
Pays : United States
Organisme : NIH HHS
ID : UG1 OD024956
Pays : United States
Organisme : NICHD NIH HHS
ID : U10 HD036790
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD068278
Pays : United States
Organisme : NIH HHS
ID : UG1 OD024955
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD068263
Pays : United States
Organisme : NIH HHS
ID : UG1 OD024945
Pays : United States
Organisme : NIH HHS
ID : UG1 OD024953
Pays : United States
Organisme : NIH HHS
ID : UG1 OD024950
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD068244
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD027853
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD053089
Pays : United States
Organisme : NIH HHS
ID : UG1 OD024947
Pays : United States
Organisme : NIH HHS
ID : UG1 OD024948
Pays : United States
Organisme : NIH HHS
ID : UG1 OD024959
Pays : United States
Organisme : NIH HHS
ID : U24 OD024957
Pays : United States
Organisme : NIH HHS
ID : UG1 OD024954
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD040492
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD021364
Pays : United States
Investigateurs
Akshatha Akshatha
(A)
Erica F Braswell
(EF)
Andrew A Bremer
(AA)
Jaime Brown
(J)
Lori Christ
(L)
Margaret M Crawford
(MM)
Moira Crowley
(M)
Abhik Das PhD
(AD)
Lori A Devlin
(LA)
Krishna Dummula
(K)
Camille M Fung
(CM)
Rachel G Greenberg
(RG)
Devon W Hahn
(DW)
Rosemary D Higgins
(RD)
Meghan P Howell
(MP)
Zhuopei Hu Ms
(ZH)
Jeannette Y Lee
(JY)
Jessie R Maxwell
(JR)
Jennifer M McAllister
(JM)
Karen R McAlmon
(KR)
Stephanie L Merhar
(SL)
Sarah Newman
(S)
Songthip Ounpraseuth
(S)
David A Paul
(DA)
Brenda B Poindexter
(BB)
Karen M Puopolo
(KM)
Anne Marie Reynolds
(AM)
Julie Riccio
(J)
Ward Rice
(W)
Julie Ross
(J)
Sophie K Shaikh
(SK)
Alan E Simon
(AE)
P Brian Smith
(PB)
Jessica N Snowden
(JN)
Sucheta Telang
(S)
Lauren Tucker
(L)
Michele C Walsh
(MC)
Julie Weiner
(J)
Jessica R White
(JR)
Kara Wong Ramsey
(K)
Tanner Wright
(T)
Leslie W Young
(LW)
Informations de copyright
Copyright © 2023 Massachusetts Medical Society.
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