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

Basic Details
Date Posted
Tuesday, November 27, 2018
Status
Complete
Health Outcome(s)
neonatal enteroviral sepsis (NES)
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.

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