Necker-Enfants-Malades
Paris, 75015, France
NCT Number: NCT02139423
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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All sexes
Interventional
Not applicable
Paris, 75015, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: CMV PCR results are communicated to the relevant clinicians in real time.
Time frame: 1 month
Time frame: 4 months
correlation between the results obtained from saliva and from blood (isolated from Guthrie cards)
Time frame: 4 months
Time frame: 4 months
Assistance Publique - Hôpitaux de Paris
Other
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
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