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

Project Title Quantifying Prevalence and Mortality Associated with Neonatal Enteroviral Sepsis (NES) Using Inpatient Data in FDA’s Sentinel System
Date Posted
Tuesday, November 27, 2018
Status
Complete
Deliverables
Related Links
Description

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.

Health Outcome
neonatal enteroviral sepsis (NES)
Population / Cohort
All children 60 days of age and younger
Time Period
July 1, 2012 - March 31, 2016
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER