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Quantifying Prevalence and Mortality Associated with Neonatal Enteroviral Sepsis (NES) Using Inpatient Data in FDA’s Sentinel System

    Basic Details
    Date Posted
    Health Outcome(s)
    neonatal enteroviral sepsis (NES)

    Neonatal enteroviral sepsis (NES) is a severe enterovirus (EV) infection in the neonate that may manifest with serious complications such as hepatic necrosis, coagulopathy, and myocarditis. Currently no U.S. Food and Drug Administration (FDA) approved drug product exists for the treatment of NES, although reports indicate intravenous immune globulin (IVIG) is sometimes administered. FDA required observational data on NES prevalence and mortality rates to inform the design of future clinical trials to evaluate investigational new drugs for NES treatment. The objective of this project is to describe NES prevalence and mortality rates among hospitalized neonates in the Sentinel System.

    Additional Details
    FDA Center
    Time Period
    July 1, 2012 - March 31, 2016
    Analysis Type
    Custom Code
    Population / Cohort
    All children 60 days of age and younger
    Data Sources
    Sentinel Distributed Database (SDD)