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NCT Number: NCT07335874

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

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.

Recruiting

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Key information

Age range

0 year–1 month

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Carine EYERMANN, MD

CONTACT

[email protected]

33 3 88 12 76 56

Carine EYERMANN, MD

PRINCIPAL_INVESTIGATOR

Guillaume TRAU, MD

SUB_INVESTIGATOR

Hélène MARECHAL, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Carine EYERMANN, MD

CONTACT

[email protected]

33 3 88 12 76 56

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: cCMV-DNS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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