NCT02139423

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 235 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 1 Day – 10 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Cytomegalovirus Infection

Interventions

Type	Name	Description
OTHER	CMV PCR

Timeline

• Start date: 2014-11-22
• Primary completion: 2018-03-31
• Completion: 2020-10-19
• First posted: 2014-05-15
• Last updated: 2026-03-27

Locations

1 site across 1 country: France