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

NCT07335874 | Recruiting

• 1 other identifier: 9689
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Hearing Loss

Keywords

Neonatal hearing loss; Cytomegalovirus infection; Congenital infection; Sensorineural hearing loss

Outcome Measures

Primary Outcomes (1)

• CMV PCR rates (in %) in infants with inconclusive T2 at the newborn hearing screening (DNS)

  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)

  Up to 12 months

Eligibility Criteria

• Age: 0 Years - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

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

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Cytomegalovirus Infections; Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Carine EYERMANN, MD

CONTACT

33 3 88 12 76 56; carine.eyermann@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 13, 2026
• Study Start: June 16, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 16, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

FR (1)