Neonatal Hearing LosscCMV-DNSNCT07335874
Overview of Targeted Screening for Congenital Infection Guided by Neonatal Hearing Screening
An observational study of Neonatal Hearing Loss, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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.). Read more about this study
- Who is it for?
- Ages 0 years to 1 month
- Conditions the study is for
- Neonatal Hearing Loss
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2025to 16 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years to 1 month
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Positive CMV PCR after 1 month of life
- CMV PCR performed for another indication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service d'ORL et de Chirurgie Cervico-faciale - CHU de Strasbourg - France
Strasbourg, 67091
Carine EYERMANN, MD, 33 3 88 12 76 56, carine.eyermann@chru-strasbourg.fr
Carine EYERMANN, MD
About this study
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.
Read more
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
- Medical subject headings
- Cytomegalovirus Infections, Hearing Loss, Sensorineural
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start16 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completion16 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Hearing LossStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335874
- Sponsor's protocol ID
- 9689
- Acronym
- cCMV-DNS
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overview of Targeted Screening for Congenital Infection Guided by Neonatal Hearing Screening
- ClinicalTrials.gov ID
- NCT07335874
- Acronym / sponsor ID
- cCMV-DNS / 9689
- Conditions
- Neonatal Hearing Loss
- Keywords
- Neonatal hearing loss, Cytomegalovirus infection, Congenital infection, Sensorineural hearing loss
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- 16 Jun 2026 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 years to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Positive CMV PCR after 1 month of life
- CMV PCR performed for another indication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
Related trials for Neonatal Hearing Loss
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Towards Implementation of Universal Newborn Hearing Screening in Kenya
Hearing Loss, Bilateral or Unilateral, Otitis Media With Effusion in Children
RecruitingPhase 1/2
A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)
Primary Photoreceptor Disease, Retinitis Pigmentosa (RP)
RecruitingPhase 3
KHENERFIN Study: A Trial to Evaluate the Efficacy and Safety of Sonlicromanol in Primary Mitochondrial Diseases
Mitochondrial Diseases, Maternally Inherited Diabetes and Deafness (MIDD)
RecruitingPhase 3
A 24-Month Trial of NPI-001 for the Preservation of Photoreceptors in Retinitis Pigmentosa Associated With Usher Syndrome
Retinitis Pigmentosa (RP), Usher Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Hearing Loss, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carine EYERMANN, MD (33 3 88 12 76 56, carine.eyermann@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMV PCR rates (in %) in infants with inconclusive T2 at the newborn hearing screening (DNS) (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.