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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Congenital Cytomegalovirus Infection

Intervention / Treatment
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* Other: CMV PCR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 10 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All newborns who fail universal newborn<br>CMV PCR | Other: CMV PCR<br> <br> * Other names: CMV PCR results are communicated to the relevant clinicians in real time.;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of CMV by quantitative PCR | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congenital cytomegalovirus infection, newborn universal hearing screening