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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Congenital Cytomegalovirus Infection

Treatments: Other: CMV PCR

Study type: Interventional

Funder types: Other

Identifiers

NCT02139423

CRC12025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 235 patients

Sex: All

Ages: 1 to 10 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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235 participants in 1 patient group

All newborns who fail universal newborn

Experimental group

Description:

CMV PCR

Treatment:

Other: CMV PCR