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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Scre

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 Summary: 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 improved 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; diagnosis 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.
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Number of days necessary to obtain the result of cCMV infection diagnosis and the audiological result after formal assessment [ Time Frame: 1 month ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Measurement of CMV by quantitative PCR [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 4 months ]


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: April 28, 2014
Date Started: November 2014
Date Completion: November 2018
Last Updated: August 23, 2016
Last Verified: August 2016