DMID 19-0026 Enterovirus Study 

Neonatal Enterovirus and Human Parechovirus Viral Sepsis: Natural History and Predictors of Morbidity and Mortality 

This study will be the first large, multi-state prospective assessment of the viral causes of neonatal sepsis conducted. The main reason for this research study is to get a better understanding of what causes neonatal viral sepsis and to assess the impact of the infection on the babies’ health. Viruses called enterovirus (EV) or human parechovirus (HPeV) are very common in the population and can cause neonatal viral sepsis. By gaining a better understanding of the condition, we hope this information can be used to guide diagnosis and treatment of babies with neonatal viral sepsis in the future. 

DMID 19-0005 Acute Flaccid Myelitis (AFM) Study

A Prospective Study of Acute Flaccid Myelitis (AFM) to Define Natural History, Risk Factors and Pathogenetic Mechanisms

Patients with suspected AFM (onset of flaccid limb weakness within the previous 30 days) are eligible to enroll in the study. Investigators will assess participants at four-time points within the first month of enrollment and will ask participants to return for additional follow up visits at 3 months, 7 months and 1 year. Neurologic improvements will be tracked over time, and samples will be collected and stored in a biorepository for use in future research studies. Household contacts, such as siblings, will be eligible to participate in the study as a control or comparison group.

This study is actively enrolling subjects.

DMID 16-0095  Asymptomatic CMV Treatment Study

A Phase II, Single-Stage, Single-Arm Investigation of Oral Valganciclovir Therapy in Infants with Asymptomatic Congenital Cytomegalovirus Infection

The purpose of this study is to evaluate if using Valganciclovir as a treatment to prevent sensorineural hearing loss in babies born with an infection called congenital Cytomegalovirus (CMV) is helpful. Congenital means that it occurred before birth. We are looking for babies who were born with no outward symptoms (asymptomatic) of this infection and were not tested at birth. Valganciclovir is the approved drug that doctors currently use for the treatment of congenital CMV infection. This drug is used in babies born with outward symptoms (symptomatic) and who have had a confirmed positive CMV test done after delivery. Valganciclovir has been shown in earlier studies to be effective in preventing hearing loss or hearing deterioration in babies with symptomatic CMV disease.

Enrollment for this study has been halted until further notice.