Newborns greater than or equal to 32 weeks gestation will be screened for congenital Cytomegalovirus (CMV) infection. Congenital infections occur while a baby is still in the mother’s womb. It is estimated that 5 to 10 out of every 1000 babies born will have a congenital CMV infection. Although most babies with congenital CMV infection do not have any problems due to the virus, around 15% will have hearing loss, visual problems, and/or physical or developmental disabilities. The hearing loss due to congenital CMV infection can be present at birth or can develop later during childhood. Overall, congenital CMV is a rare infection at birth, but it accounts for 21% of hearing loss at birth and 24% of hearing loss by age 4.
Newborns that are screened and confirmed to have congenital CMV infection will be offered enrollment into either the observational phase or the treatment phase of the study. This study is being done to evaluate if treatment with an approved drug called Valganciclovir will reduce the risk of hearing loss in babies with congenital CMV were born with no outward symptoms of the infection.
Newborns greater than or equal to 32 weeks gestation.