Enteroviral (EV) sepsis with hepatic necrosis and coagulopathy (HNC) or myocarditis is a serious and life-threatening infection. This serious infection primarily affects neonates and is sometimes referred to as neonatal enterovirus sepsis syndrome (NES). The current incidence of NES is not well described. The reported case fatality rate among infants varies across the literature from 0% to 100%.
The case fatality rate among neonates may be dependent on several factors including the presence of myocarditis, other baseline characteristics, overall severity of the illness, and the enterovirus strain circulating during a specific season. In addition, the overall mortality rate may be decreasing over time with the availability of improved and state-of-the-art intensive care units.
The FDA has an interest in exploring data sources to obtain real world evidence regarding the current natural history and mortality associated with NES to better inform regulatory decision making.
The study has 2 aims.
Aim 1: Examine the case fatality rate among hospitalized neonates with NES.
Aim 2: Examine the clinical course of the disease, such as
– Time to death (from admission)
– Length of hospitalization
– Length of ICU stay
– Duration of mechanical intubation or other invasive support such as ECMO
– Use of investigational (antiviral) products, including IVIG
– Proportion of subjects requiring pressor support