Pragmatic, randomized, blinded trial to shorten pharmacologic treatment of newborns with neonatal opioid withdrawal syndrome (NOWS)
Year: 2023
Type: article
Study design: Study Protocol
Abstract: BACKGROUND: The incidence of maternal opioid use in the USA has increased substantially since 2000. As a consequence of opioid use during pregnancy, the incidence of neonatal opioid withdrawal syndrome (NOWS) has increased fivefold between 2002 and 2012. Pharmacological therapy is indicated when signs of NOWS cannot be controlled, and the objective of pharmacological therapy is to control NOWS signs. Once pharmacologic therapy has started, there is great variability in strategies to wean infants. An important rationale for studying weaning of pharmacological treatment for NOWS is that weaning represents the longest time interval of drug treatment. Stopping medications too early may not completely treat NOWS symptoms. METHODS: This will be a pragmatic, randomized, blinded trial of opioid weaning to determine whether more rapid weaning, compared to slow wean, will reduce the number of days of opioid treatment in infants receiving morphine or methadone as the primary treatment for NOWS. DISCUSSION: The proposed study is a pragmatic trial to determine whether a rapid-weaning intervention reduces the number of days of opioid treatment, compared to a slow-weaning intervention, and we powered the proposed study to detect a 2-day difference in the length of treatment. Hospitals will be able to use either morphine or methadone with the knowledge that we may find a positive treatment effect for both, one, or neither drugs. TRIAL REGISTRATION: NCT04214834. Registered January 2, 2020.
Source: Trials
Authors: Adam Czynski, Abbot Laptook, Abhik Das, Brian Smith, Alan Simon, Rachel Greenberg, Robert Annett, Jeannette Lee, Jessica Snowden, Claudia Pedroza, Barry Lester, Barry Eggleston, Drew Bremer, Elisabeth McGowan
Institutions: Connecticut Children's Medical Center, Brown University, Women & Infants Hospital of Rhode Island, RTI International, Duke Clinical Research Institute, National Institutes of Health, University of Mississippi, University of Arkansas Medical Center, University of Arkansas for Medical Sciences
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,390
Funders: U.S. Department of Health and Human Services, Ohio State University, Tulane University, University of Arkansas for Medical Sciences, Central Michigan University, Loma Linda University, University of South Florida, West Virginia University, National Institutes of Health, Health Science Center, University of Tennessee, National Institute of Child Health and Human Development, National Center for Advancing Translational Sciences, Eunice Kennedy Shriver National Institute of Child Health and Human Development
OpenAlex ID: W4385064569