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OpenTrials
Completed

NCT Number: NCT02139423

Diagnosis of Congenital CMV Infection in Neonates 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.

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Key information

Age range

1 day–10 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necker-Enfants-Malades

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

CMV PCR

Other

Other names: CMV PCR results are communicated to the relevant clinicians in real time.

Primary outcomes

  1. Number of days necessary to obtain the result of cCMV infection diagnosis and the audiological result after formal assessment

    Time frame: 1 month

Secondary outcomes

  1. Measurement of CMV by quantitative PCR

    Time frame: 4 months

    correlation between the results obtained from saliva and from blood (isolated from Guthrie cards)

  2. Number of children for whom the result of the formal audiological assessment has been obtained

    Time frame: 4 months

  3. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study 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

Acronym: CYMEAUDIT

Important dates

Study start
2014
Primary completion
2018
Study completion
2020
First posted
May 15, 2014
Registry last updated
Mar 27, 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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