CLINICAL TRIAL: HEALTH IMPACT OF CONGENITAL CYTOMEGALOVIRUS INFECTION

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The overall objective of this proposal is to define the epidemiology and disease burden of congenital infection caused by Human Cytomegalovirus (HCMV), in a diverse, Northern California population by virologically screening 20,000 newborns from three area hospitals over a two-year period. HCMV is an ubiguitous member of the herpes virus family. Screening will be done using a direct early antigen detection of fluorescent foci (DEAFF) method to identify HCMV in saliva samples of newborns. To assess disease burden, we will document the clinical manifestations in infected infants and determine the distribution of symptomatic vs. asymptomatic presentation using specific case definitions and classification criteria. We will describe the incidence, severity and timing of onset of sensorineural hearing loss (SNHL) over three years in infected infants enrolled in a prospective hearing screening program and determine whether, or the extent to which, universal newborn hearing screening identifies SNHL caused by congenital HCMV infection. In addition, we will describe the development of HCMV-specific CD4 and CD8 T-cell responses of infected infants during the first three years of life to assess differences in immune response patterns between symptomatically and asymptomatically infected infants.