Actively Recruiting

Age: 0Years - 1Month
All Genders
NCT07335874

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

Age: 0Years - 1Month
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Service d'ORL et de Chirurgie Cervico-faciale - CHU de Strasbourg - France

Strasbourg, France, 67091

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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