Congenital Cytomegalovirus Infection
Conditions
Keywords
Congenital cytomegalovirus infection, newborn universal hearing screening
Brief 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. 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.
Interventions
OTHERCMV PCR
Sponsors
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 10 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of days necessary to obtain the result of cCMV infection diagnosis and the audiological result after formal assessment | 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of CMV by quantitative PCR | 4 months | correlation between the results obtained from saliva and from blood (isolated from Guthrie cards) |
| Number of children for whom the result of the formal audiological assessment has been obtained | 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 | 4 months | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORMarianne Leruez-Ville, MD, PhD
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed