Overview of Targeted Screening for Congenital Infection Guided by Neonatal Hearing Screening

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07335874

Acronym

cCMV-DNS

Enrollment

450

Registered

2026-01-13

Start date

2025-06-16

Completion date

2026-06-16

Last updated

2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Hearing Loss

Keywords

Neonatal hearing loss, Cytomegalovirus infection, Congenital infection, Sensorineural hearing loss

Brief summary

Cytomegalovirus (CMV) infection is the most common congenital infection. It is the second leading cause of sensorineural hearing loss after genetic causes and the leading cause of motor delay. It can also cause ophthalmological or biological abnormalities (hepatic cytolysis, thrombocytopenia, etc.). Currently, routine screening during pregnancy or at birth is not recommended. 90% of infected infants are asymptomatic at birth. However, 10 to 25% of them present with hearing loss at birth or will develop it in their first years of life. This hearing loss is progressive. In the context of deafness, detecting congenital CMV infection helps explain the cause of hearing loss (a recurring question from parents) and allows for tailored management and follow-up (progressive deafness, bilateral involvement). Its detection also enables appropriate pediatric monitoring (neurological, ophthalmological, etc.). Screening for congenital CMV infection (cCMV), guided by neonatal hearing screening, has been recommended by the French High Council for Public Health (HCSP) since 2018. In cases of confirmed congenital CMV infection, an ophthalmological examination (fundus examination), hearing test, brain imaging, and blood tests are performed. The investigators wish to collect data from targeted screening for congenital CMV infection at the Strasbourg University Hospitals (HUS) to ensure comprehensiveness and to study CMV-related conditions in these screened children.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Years to 1 Months

Healthy volunteers

Inclusion criteria

* Minors aged 0 to 1 month at the time of newborn hearing screening * Subject with inconclusive newborn hearing screening (NHS) on unilateral or bilateral T2 (inconclusive retest) between August 2024 and the end of July 2025.

Exclusion criteria

* Positive CMV PCR after 1 month of life * CMV PCR performed for another indication.

Design outcomes

Primary

Measure	Time frame	Description
CMV PCR rates (in %) in infants with inconclusive T2 at the newborn hearing screening (DNS)	Up to 12 months	CMV PCR rates in infants with inconclusive T2 at the newborn hearing screening (DNS) (number of PCR tests performed / total number of infants with inconclusive T2)

Countries

France

Contacts

Primary ContactCarine EYERMANN, MD

carine.eyermann@chru-strasbourg.fr33 3 88 12 76 56

Outcome results