In the United States, congenital cytomegalovirus (CMV) infection is the most common viral cause of mental retardation and is a leading cause of hearing loss.  From 1991 through 1999, 100 babies with the same disease as your baby were enrolled into a study to evaluate the risks versus the benefits of using the drug ganciclovir.  The infants in this study who received 6 weeks of IV (given by vein) ganciclovir had less hearing loss at 6 months than babies who did not receive the drug.  The effect on protecting against hearing loss lasted beyond 1 year of life.

Further improvement of neurological and hearing functions for babies with this disease may require a longer treatment course than 6 weeks.  However, ganciclovir can only be given by IV.  The purpose of this study is to compare the impact on hearing and neurological outcome of babies that receive 6 weeks versus 6 months of valganciclovir. It is not known if 6 months of treatment with valganciclovir results in better hearing and neurological outcomes than treatment with valganciclovir for 6 weeks.  Both of these treatment courses are experimental as valganciclovir is not approved for babies and children. We also want to learn if there are any side effects of giving valganciclovir to babies 6 weeks versus 6 months.