Diagnosis of Congenital CMV Infection in Neonates Who Failed Newborn Hearing Screening (CYMEAUDIT)

March 23, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

235

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Necker-Enfants-Malades

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All newborns who have failed universal newborn screening

Exclusion Criteria:

  • Neonates whose mothers would object to the use of their child's medical data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All newborns who fail universal newborn
CMV PCR
Other: CMV PCR
Other Names:
  • CMV PCR results are communicated to the relevant clinicians in real time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of days necessary to obtain the result of cCMV infection diagnosis and the audiological result after formal assessment
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of CMV by quantitative PCR
Time Frame: 4 months
correlation between the results obtained from saliva and from blood (isolated from Guthrie cards)
4 months
Number of children for whom the result of the formal audiological assessment has been obtained
Time Frame: 4 months
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
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

Investigators

  • Principal Investigator: Marianne Leruez-Ville, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2014

Primary Completion (Actual)

March 31, 2018

Study Completion (Actual)

October 19, 2020

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

May 12, 2014

First Posted (Estimated)

May 15, 2014

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K120903
  • CRC12025 (Other Identifier: CRC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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