Expanded Newborn Screening Program Increases Detection of Congenital Cytomegalovirus

Congenital cytomegalovirus is the most common maternal–fetal infection and often goes undetected at birth, despite its potential to cause progressive hearing loss and developmental delays. In the United States, newborn testing is typically prompted by failed hearing screens, symptoms, or maternal concerns, leaving many infections unidentified. Screening practices also vary widely as states and hospitals adopt different policies without unified guidance. A new study now shows that a system-wide newborn screening program substantially increased detection of congenital cytomegalovirus.

Cleveland Clinic Children’s has implemented an expanded newborn screening program for congenital cytomegalovirus (cCMV) across its Ohio locations to identify infected infants earlier in routine care. The initiative, introduced between 2022 and 2025 in newborn nurseries and neonatal intensive care units (NICUs), begins with a swab-based screening test followed, when indicated, by confirmatory urine testing. Findings from the program were published in Pediatrics on September 21, 2026.

Image: cCMV screening is not universal in U.S. newborns, yet over 40% of children who develop related hearing loss initially pass newborn hearing screening, highlighting the need for broader approaches (Image Credit: iStock)

During the implementation period, more than 50,000 babies were born at Cleveland Clinic facilities, with nearly 7,500 receiving cCMV screening. Annual testing volume increased from approximately 150 infants per year to more than 2,000. The expanded program identified 34 infants with cCMV, representing about a 2.5-fold increase in detection compared with previous practice.

cCMV screening is not currently universal for all newborns in the United States and is more commonly performed after a failed hearing screen, in symptomatic infants, or when maternal complications raise concern. However, according to the National Institutes of Health, more than 40% of children who later develop cCMV-related hearing loss initially pass their newborn hearing screen. These findings have been cited in support of broader screening approaches that do not rely solely on hearing status.

“Our findings show that this screening is practical and effective. Identifying affected babies earlier allows for monitoring and ultimately treatment, helping to improve long-term outcomes,” said Frank Esper, M.D., senior author and pediatric infectious disease specialist at Cleveland Clinic Children's.

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