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    Model-Based Approach to Improve Clinical Outcomes in Neonates With Opioid Withdrawal Syndrome Using Real-World Data

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    Author
    Wijekoon, N.
    Aduroja, O.
    Biggs, J.M.
    El-Metwally, D.
    Gopalakrishnan, M.
    Date
    2020-10-29
    Journal
    Clinical Pharmacology and Therapeutics
    Publisher
    Wiley
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.1002/cpt.2093
    Abstract
    At least 60% of the neonates with opioid withdrawal syndrome (NOWS) require morphine to control withdrawal symptoms. Currently, the morphine dosing strategies are empiric, not optimal and associated with longer hospital stay. The aim of the study was to develop a quantitative, model-based, real-world data-driven approach to morphine dosing to improve clinical outcomes, such as reducing time on treatment. Longitudinal morphine dose, clinical response (Modified Finnegan Score (MFS)), and baseline risk factors were collected using a retrospective cohort design from the electronic medical records of neonates with NOWS (N = 177) admitted to the University of Maryland Medical Center. A dynamic linear mixed effects model was developed to describe the relationship between MFS and morphine dose adjusting for baseline risk factors using a split-sample data approach (70% training: 30% test). The training model was evaluated in the test dataset using a simulation based approach. Maternal methadone and benzodiazepine use, and race were significant predictors of the MFS response. Positive autocorrelations of 0.56 and 0.12 were estimated between consecutive MFS responses. On an average, for a 1,000 ?g increase in the morphine dose, the MFS decreased by 0.3 units. The model evaluation showed that observed and predicted median time on treatment were similar (13.0 vs. 13.8 days). A model-based framework was developed to describe the MFS -morphine dose relationship using real-world data that could potentially be used to develop an adaptive, individualized morphine dosing strategy to improve clinical outcomes in infants with NOWS. Copyright 2020 The Authors. Clinical Pharmacology & Therapeutics Copyright 2020 American Society for Clinical Pharmacology and Therapeutics
    Sponsors
    This study was funded by a Science to Systems Grant (SSG) Program from the University of Maryland, Baltimore - Center for Addiction Research, Education and Service (UMB CARES).
    Keyword
    model-based
    Morphine--therapeutic use
    Neonatal Abstinence Syndrome--drug therapy
    Opioid-Related Disorders--drug therapy
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/15348
    ae974a485f413a2113503eed53cd6c53
    10.1002/cpt.2093
    Scopus Count
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