Congenital Cytomegalovirus InfectionCYMEAUDITNCT02139423
Diagnosis of Congenital CMV Infection in Neonates Who Failed Newborn Hearing Screening
A study testing CMV PCR in people with Congenital Cytomegalovirus Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Universal hearing screening at birth by use of otoacoustic emission (OAE) is now offered in most maternities in France to detect symptomatic hearing impairment at birth but screening of cCMV infection is not coupled with this screening. Read more about this study
- Who is it for?
- Ages 1 day to 10 days
- Conditions the study is for
- Congenital Cytomegalovirus Infection
- What is being tested?
- CMV PCR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2014to 19 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 day to 10 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All newborns who have failed universal newborn screening
Who cannot join
- Neonates whose mothers would object to the use of their child's medical data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility to Achieve, Before One Month of Age, the Diagnosis of Congenital CMV Diagnosis and the Formal Audiologic Assessment in Newborns Who Failed Newborn Hearing Screening
Universal hearing screening at birth by use of otoacoustic emission (OAE) is now offered in most maternities in France to detect symptomatic hearing impairment at birth but screening of cCMV infection is not coupled with this screening. In this study, the feasibility of achieving before one month of age the diagnosis of congenital CMV diagnosis and as well as the confirmation of hearing loss in newborns who failed newborn hearing screening will be tested.
Read the detailed description
Congenital cytomegalovirus (cCMV) is the most frequent congenital infection in France. Around 90% of cCMV infected infants are asymptomatic at birth, of whom 7 to 20% develop sensorineural hearing loss (SNHL). cCMV explains at least 10% of all hearing loss cases in young children. Early antiviral treatment (implemented before 1 month of age) with ganciclovir or valganciclovir can improve hearing outcome. In the absence of universal screening, cCMV remains largely undetected because most infected neonates are asymptomatic or have non-specific symptoms. When symptoms become apparent or develop, it may be too late for confirmation that the infection is of congenital origin becausediagnosis of congenital infection is based on the detection of CMV in samples collected within 2 to 3 weeks after birth. The presence of CMV in samples collected after this time may represent postnatal infection which does not carry the risk of hearing loss or neurodevelopmental sequelae. Universal hearing screening at birth by use of otoacoustic emission (OAE) is now offered in most maternities in France to detect symptomatic hearing impairment at birth but screening of cCMV infection is not coupled with this screening. In this study, the feasibility of achieving before one month of age the diagnosis of congenital CMV diagnosis and as well as the confirmation of hearing loss in newborns who failed newborn hearing screening will be tested.
- Conditions
- Congenital Cytomegalovirus Infection
- Being tested
- CMV PCR
- Keywords
- Congenital cytomegalovirus infection, newborn universal hearing screening
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMV PCROther
Also called CMV PCR results are communicated to the relevant clinicians in real time.
| Study group | Role | What they receive |
|---|---|---|
| All newborns who fail universal newborn | Experimental | CMV PCR Receives: Other: CMV PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days necessary to obtain the result of cCMV infection diagnosis and the audiological result after formal assessment
Measured: 1 month
Secondary outcomes (3)
Measurement of CMV by quantitative PCR
correlation between the results obtained from saliva and from blood (isolated from Guthrie cards)
Measured: 4 months
Number of children for whom the result of the formal audiological assessment has been obtained
Measured: 4 months
Number of children with cCMV infection and confirmed hearing loss in whom antiviral therapy has been initiated within the first month of life
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study start22 Nov 2014
- Primary completion31 Mar 2018
- Study completion19 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Cytomegalovirus InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Marianne Leruez-Ville, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139423
- Sponsor's protocol ID
- K120903
- Other IDs
- CRC12025
- Acronym
- CYMEAUDIT
- Status last verified
- Mar 2026
- First submitted
- 28 Apr 2014
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Fourgeaud J, Boithias C, Walter-Nicolet E, Kermorvant E, Couderc S, Parat S, Pol C, Mousset C, Bussieres L, Guilleminot T, Ville Y, Nkam L, Grimaldi L, Parodi M, Leruez-Ville M. Performance of Targeted Congenital Cytomegalovirus Screening in Newborns Failing Universal Hearing Screening: A Multicenter Study. Pediatr Infect Dis J. 2022 Jun 1;41(6):478-481. doi: 10.1097/INF.0000000000003474. Epub 2022 Jan 27.
PubMed 35093998
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility to Achieve, Before One Month of Age, the Diagnosis of Congenital CMV Diagnosis and the Formal Audiologic Assessment in Newborns Who Failed Newborn Hearing Screening
- ClinicalTrials.gov ID
- NCT02139423
- Acronym / sponsor ID
- CYMEAUDIT / K120903
- Conditions
- Congenital Cytomegalovirus Infection
- Keywords
- Congenital cytomegalovirus infection, newborn universal hearing screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 22 Nov 2014 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 19 Oct 2020 (actual)
- First posted
- 15 May 2014 (estimated)
- 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.
Universal hearing screening at birth by use of otoacoustic emission (OAE) is now offered in most maternities in France to detect symptomatic hearing impairment at birth but screening of cCMV infection is not coupled with this screening. In this study, the feasibility of achieving before one month of age the diagnosis of congenital CMV diagnosis and as well as the confirmation of hearing loss in newborns who failed newborn hearing screening will be tested.
Detailed description
Congenital cytomegalovirus (cCMV) is the most frequent congenital infection in France. Around 90% of cCMV infected infants are asymptomatic at birth, of whom 7 to 20% develop sensorineural hearing loss (SNHL). cCMV explains at least 10% of all hearing loss cases in young children. Early antiviral treatment (implemented before 1 month of age) with ganciclovir or valganciclovir can improve hearing outcome. In the absence of universal screening, cCMV remains largely undetected because most infected neonates are asymptomatic or have non-specific symptoms. When symptoms become apparent or develop, it may be too late for confirmation that the infection is of congenital origin becausediagnosis of congenital infection is based on the detection of CMV in samples collected within 2 to 3 weeks after birth. The presence of CMV in samples collected after this time may represent postnatal infection which does not carry the risk of hearing loss or neurodevelopmental sequelae. Universal hearing screening at birth by use of otoacoustic emission (OAE) is now offered in most maternities in France to detect symptomatic hearing impairment at birth but screening of cCMV infection is not coupled with this screening. In this study, the feasibility of achieving before one month of age the diagnosis of congenital CMV diagnosis and as well as the confirmation of hearing loss in newborns who failed newborn hearing screening will be tested.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All newborns who fail universal newborn | Experimental | Other: CMV PCRCMV PCR |
Who may qualify
- Ages
- 1 day to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All newborns who have failed universal newborn screening
Key exclusion criteria (1 listed)
- Neonates whose mothers would object to the use of their child's medical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMV PCRAlso: CMV PCR results are communicated to the relevant clinicians in real time. | Other | All newborns who fail universal newborn |
Primary outcome
Number of days necessary to obtain the result of cCMV infection diagnosis and the audiological result after formal assessment
Time frame: 1 month
3 secondary outcomes
Measurement of CMV by quantitative PCR
Time frame: 4 months
Number of children for whom the result of the formal audiological assessment has been obtained
Time frame: 4 months
Number of children with cCMV infection and confirmed hearing loss in whom antiviral therapy has been initiated within the first month of life
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Results publication: PubMed 35093998Fourgeaud J, Boithias C, Walter-Nicolet E, Kermorvant E, Couderc S, Parat S, Pol C, Mousset C, Bussieres L, Guilleminot T, Ville Y, Nkam L, Grimaldi L, Parodi M, Leruez-Ville M. Performance of Targeted Congenital Cytomegalovirus Screening in Newborns Failing Universal Hearing Screening: A Multicenter Study. Pediatr Infect Dis J. 2022 Jun 1;41(6):478-481. doi: 10.1097/INF.0000000000003474. Epub 2022 Jan 27.
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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. This study is not recruiting at the moment.
Marianne Leruez-Ville, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMV PCR in people with Congenital Cytomegalovirus Infection, run by Assistance Publique - Hôpitaux de Paris 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days necessary to obtain the result of cCMV infection diagnosis and the audiological result after formal assessment (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02139423, which also lists 1 linked publication.
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 27 Mar 2026.