Actively Recruiting
Overview of Targeted Screening for Congenital Infection Guided by Neonatal Hearing Screening
Led by University Hospital, Strasbourg, France · Updated on 2026-01-13
450
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Overview of Targeted Screening for Congenital Infection Guided by Neonatal Hearing Screening
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Minors aged 0 to 1 month at the time of newborn hearing screening
- Newborns with inconclusive hearing screening results on one or both ears (unilateral or bilateral T2 retest) between August 2024 and July 2025
You will not qualify if you...
- Positive CMV PCR test after 1 month of age
- CMV PCR test performed for reasons other than newborn hearing screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Service d'ORL et de Chirurgie Cervico-faciale - CHU de Strasbourg - France
Strasbourg, France, 67091
Actively Recruiting
Research Team
C
Carine EYERMANN, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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