Congenital cytomegalovirus (cCMV) infection is the most infectious disease complicating pregnant person – infant dyads in the United States (US), and probably globally. When CMV is transmitted prenatally, it can result in significant long-term disabilities in 15-20% of infected infants. The most common disability is sensorineural hearing loss. Longitudinal assessment of congenitally infected infants is vital, since in up to 50% of cases in which developmental and audiologic disability occurs, there is no evident of CMV disease at birth. Since there is no routine screening test at birth for congenital CMV, there are uncertainties about the natural history of transplacentally acquired infections, particularly in asymptomatic (but infected) newborns. Against this knowledge deficit, we propose to perform longitudinal assessments of a cohort of 87 congenitally infected infants identified between 2016-2022 in a universal screening program in Minnesota. In five Twin Cities nurseries, and one rural nursery, we have screened over 23,000 infants in this time period; as of December 2022, over 60% of infants were <4 years of age. Longitudinal follow-up information has included newborn disease classification; hematologic, biochemical, virologic, and neuroimaging data; audiologic evaluation including baseline evaluation at birth and serial audiological examination; ophthalmological studies; cranial MRI data; and neurodevelopmental outcome data, including the results of assessments with the Bayley scales of infant development. In collaboration with the bioinformatics group at the University of Minnesota we will collect this baseline and longitudinal data, emphasizing metrics for data validation to ensure that data extraction is accurate in screen-positive infants confirmed to have congenital infection. In collaboration with the National Center on Birth Defects and Developmental Disabilities at the CDC, the analysis of this novel collection of infants will h
elp inform and direct the nascent field of universal congenital CMV screening, and fulfill the purpose and mission of this RFA by defining the impact of CMV exposures on outcomes for this unsolved infectious disease problem, which is of considerable public health interest.