Cytomegalovirus Testing and Intervention Protocol for Newborn Nursery and Newborn Intensive Care Unit

Specific Aim 1: Establish a cCMV testing protocol and demonstrate that this protocol is successful at identifying infants with cCMV who present with hearing abnormality as the first sign of infection.

Specific Aim 2: Demonstrate that a majority of infants who test positive for cCMV at the time of failed hearing screen are referred within 14 days for appropriate confirmatory testing and treatment.

Specific Aim 3: Improve cCMV prevalence data estimates for the State of Nebraska.

Congenital cytomegalovirus (cCMV) affects 20,000-40,000 infants in the United States annually and is the most common congenital viral infection in newborns1. cCMV is the most common non-genetic cause of sensorineural hearing loss (SNHL) in children and it is estimated that the 1 in 10 children with SNHL have cCMV related hearing loss. SNHL is the most common sequela of cCMV infection but the overall disease burden is much greater as cCMV is an important contributor to neurodevelopmental delay2.

The most common physical exam findings for identification of cCMV include petechiae, hepatosplenomegaly, microcephaly, hypotonia, hearing loss, purpura, chorioretinitis, and seizure activity and the most common laboratory findings include elevated AST and ALT, thrombocytopenia, conjugated hyperbilirubinemia, and elevated CSF protein3,4. Infants may also be identified based on radiologic abnormalities including abnormal cranial ultrasound, head CT, and brain MRI that may show cerebral calcifications and ventriculomegaly4. Infants with cCMV infections are categorized as either symptomatic or asymptomatic based on the physical exam, laboratory, and radiologic findings that are present at birth3. Approximately 10%-15% of cCMV cases are classified as symptomatic due to the any of these clinical findings and the outcomes for these infants are poor with approximately half suffering from severe neurologic sequelae including SNHL, mental retardation with IQs < 70, and microcephaly2,3. Approximately 85-90% of children with cCMV do not have these clinical findings at birth and are therefore considered asymptomatic3.However, some cases of otherwise asymptomatic cCMV do have hearing loss as detected during newborn hearing test screening and these patients fall into a sub-categorization of asymptomatic with a failed hearing screening.The hearing loss of cCMV is significant as it is often severe to profound in both the symptomatic and asymptomatic cases. In the asymptomatic children who had hearing impairment, 42% required amplification and rehabilitation2.