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Enterovirus & Neonatal Enteroviral Sepsis

    Basic Details
    Last Updated
    Friday, May 31, 2024
    Original Posting Date
    Health Outcome(s)
    Other Regulatory
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    The U.S. Food and Drug Administration (FDA) initiated this study in the Sentinel System to describe the natural history of enterovirus sepsis among infants and neonates in the United States. Enterovirus (EV) infection in neonates can manifest as asymptomatic or mild febrile illness, or as a severe multiorgan system disease. The epidemiology of neonatal enteroviral sepsis (NES) in the United States is not well characterized, and likely varies by geography, enterovirus serotype, population, season, and testing practices. To further understand the epidemiology of NES, this study examined the prevalence of NES among hospitalized infants and described the associated mortality rate. 

    Results indicated that NES was rare with a prevalence of 0.83 per 100,000 inpatient stays. Hospital stay was longer among cases with NES and at least one organ dysfunction diagnosis. No deaths were identified. This was the first study to examine NES prevalence using inpatient data from the Sentinel System. Due to small sample size and lack of microbiology/virology data, its utility in informing future clinical trial designs was limited. No regulatory action was taken based on these data.