Eating, Sleeping, Consoling for Neonatal Opioid Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach study protocol for a multi-center, stepped-wedge randomized controlled trial

Leslie W. Young; Songthip Ounpraseuth; Stephanie L. Merhar; Alan E. Simon; Abhik Das; Rachel G. Greenberg; Rosemary D. Higgins; Jeannette Lee; Brenda B. Poindexter; P. Brian Smith; Michele Walsh; Jessica Snowden; Lori A. Devlin; for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network and the NIH Environmental influences on Child Health Outcomes (ECHO) Program Institutional Development Awards States Pediatric Clinical Trials Network

doi:10.1186/s13063-022-06445-z

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Eating, Sleeping, Consoling for Neonatal Opioid Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach study protocol for a multi-center, stepped-wedge randomized controlled trial

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Eating, Sleeping, Consoling for Neonatal Opioid Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach study protocol for a multi-center, stepped-wedge randomized controlled trial

Leslie W. Young, Songthip Ounpraseuth, Stephanie L. Merhar, Alan E. Simon, Abhik Das, Rachel G. Greenberg, Rosemary D. Higgins, Jeannette Lee, Brenda B. Poindexter, P. Brian Smith, …

Trials, Vol.23(1), pp.638-638

08-09-2022

DOI: https://doi.org/10.1186/s13063-022-06445-z

PMID: 35945598

Abstract

Study Protocol

Introduction: Background and rationale; Increased opioid use has resulted in a dramatic increase in the number of infants born with in utero opioid exposure requiring management for NOWS [1,2,3,4]. Despite the significance of this problem, numerous critical gaps remain in our knowledge with respect to the best practices for identification and management of infants with NOWS, as well as our understanding of the outcomes of these infants [5, 6]. The opioid epidemic particularly impacts rural and underserved communities represented by the ISPCTN and participating Neonatal Research Network (NRN) sites, which makes our networks well poised to address these critical gaps and improve the care of infants with NOWS.

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Title: Eating, Sleeping, Consoling for Neonatal Opioid Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach study protocol for a multi-center, stepped-wedge randomized controlled trial
Creators: Leslie W. Young - University of Vermont
Songthip Ounpraseuth - University of Arkansas for Medical Sciences
Stephanie L. Merhar - University of Cincinnati
Alan E. Simon - National Institutes of Health
Abhik Das - RTI International
Rachel G. Greenberg - Duke University
Rosemary D. Higgins - George Mason University
Jeannette Lee - University of Arkansas for Medical Sciences
Brenda B. Poindexter - Emory University
P. Brian Smith - Clinical Research Institute
Michele Walsh - Eunice Kennedy Shriver National Institute of Child Health and Human Development
Jessica Snowden - University of Arkansas for Medical Sciences
Lori A. Devlin - University of Louisville
for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network and the NIH Environmental influences on Child Health Outcomes (ECHO) Program Institutional Development Awards States Pediatric Clinical Trials Network
Publication Details: Trials, Vol.23(1), pp.638-638
Publisher: BioMed Central; LONDON
Number of pages: 35
Grant note: This research was supported by the National Institutes for Health (NIH) Helping to End Addiction Long-term (HEAL) Initiative® through administrative supplements to NIH grants U24HD095254 and U2COD023375, and NIH grant U24OD024957. Project Officers: Drew Bremer Andrew.Bremer@nih.gov and Carol Blaisdell Carol.Blaisdell@nih.gov , Rockville, MD. The NICHD and NIH ECHO staff are part of the study team and had/will have input into the study design, conduct, analysis, and manuscript drafting. The comments and views of the authors do not necessarily represent the views of the NICHD or the ECHO Program, the National Institutes of Health, the Department of Health and Human Services, or the US government. The NICHD and NIH ECHO staff provided oversight of the project through a cooperative agreement—a grant wherein the funding federal agency is substantially involved in carrying out the research program and federal scientists collaborate with researchers on a joint research project. Only National Institutes of Health staff listed as authors have contributed to this protocol.
Identifiers: 99385550120106570
Academic Unit: Office of Research & Sponsored Programs
Language: English
Resource Type: Journal article

Eating, Sleeping, Consoling for Neonatal Opioid Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach study protocol for a multi-center, stepped-wedge randomized controlled trial

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