Study

Natural History of Enteroviral Sepsis Using Real World Data


Study Dates
2022-09 - Present
Principal Investigator
Belew, Yodit
Affiliation
United States Food and Drug Administration
Sponsor Site
PEDSnet Data Coordinating Center
PEDSnet Study ID
2022.BELY.FDA.DCC.063

Study to describe the natural history and mortality related to neonatal enteroviral sepsis (NES) among neonates and infants hospitalized with enterovirus infection. Anticipated to guide future clinical trial design and in turn, help inform the pathway for drug development in this area.

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Funding

This research was made possible through the generous support of United States Food and Drug Administration.

Creative Commons license

a CC-BY 4.0 Attribution license.
Except where otherwised noted, this item's license is described as a CC-BY 4.0 Attribution license.

Publisher

PEDSnet

Project Description

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.

Study Aims

  1. Examine the case fatality rate among hospitalized neonates with NES.
  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; and proportion of subjects requiring pressor support.

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