CONGENITAL CYTOMEGALOVIRUS RESEARCH (SCREENING)

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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. Cytomegalovirus (CMV) is the most common congenital infection in humans, affecting roughly 1% of births. While most CMV-infected infants have no symptoms at birth, approximately 10% are severly symptomatic and it is possible that up to 15% of those with no symptoms at birth will develop sensorineural hearing loss (SNHL) detectable later in childhood. Of those who are symptomatic at birth, 10% will die in infancy, and it is estimated that 90% the survivors will have SNHL, mental retardation, cognitive problems, visual impairement, behavioral problems, or cerebral palsy. Recent evidence suggests that infants with neurologic involvement can have their hearing preserved or improved by treatment with IV ganciclovir. Other clinical parameters improved in the treated group such as increased head size and weight gain. A oral prodrug of ganciclovir (valganciclovir) is under evaluation which will avoid the need for 6 weeks of IV access. Now that a therapy is available for congenital CMV and there is a sensitive and specific test for identifying congenitally infected infants (urine shell vial/culture) we believe that screening for this disease is an appropriate scientific inquiry. We propose to obtain, after obtaining informed consent from the parent(s) (screening is not an accepted standard of care at this time so it must be considered research), a teaspoon of urine from every infant born at Johns Hopkins Hospital (JHH) and Johns Hopkins Bayview Hospital (JHBH), who is less than 21 days of age at the time the sample is taken and who has not had blood products or non-maternal breast milk. That urine will be sent to the Microbiology lab at JHH for CMV shell vial/culture. Parent(s) of infants who test negative will not be contacted. Parent(s) of infants who test positive will be asked to come to the PCRU and a standard work up [history and physical, review of records particularly the State required Brain Stem Evoked Response (BSER) hearing test, heme-8 with platelets, metabolic panel, and lumbar puncture] will be done to determine if the child is symptomatic or asymptomatic from their infection (for research an additional ml of blood and CSF will be taken for viral load and genetic analysis of the virus). Based on the outcome of the standard work up, medical management options for the future of the infant will be discussed with the parent(s) including research studies in which the Center is involved.