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Enterovirus & Neonatal Enteroviral Sepsis

Basic Details
Status
Complete
Last Updated
Friday, May 31, 2024
Original Posting Date
Health Outcome(s)
sepsis
Purpose
Other Regulatory
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
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.
 

Result(s) (1)
Quantifying Prevalence and Mortality Associated with Neonatal Enteroviral Sepsis (NES) Using Inpatient Data in FDA’s Sentinel System
Related Publication(s) and/or Presentation(s) (1)
Presentation: Quantifying Prevalence and Mortality Associated with Neonatal Enteroviral Sepsis (NES) Using Inpatient Data in FDA's Sentinel System