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Clinical Trials/NCT02139423
NCT02139423CompletedNot Applicable

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country235 target enrollmentStarted: November 22, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
235
Locations
1
Primary Endpoint
Number of days necessary to obtain the result of cCMV infection diagnosis and the audiological result after formal assessment

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
1 Day to 10 Days (Child)
Sex
All
Accepts 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

Arms & Interventions

All newborns who fail universal newborn

Experimental

CMV PCR

Intervention: CMV PCR (Other)

Outcomes

Primary Outcomes

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

  • Measurement of CMV by quantitative PCR(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)
  • Number of children for whom the result of the formal audiological assessment has been obtained(4 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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