Clinical trial NCT02139423: Diagnosis of Congenital CMV Infection in Neonates Who Failed Newborn Hearing Screening
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 Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Cytomegalovirus Infection
Keywords: Congenital cytomegalovirus infection
newborn universal hearing screening
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-05-15
Enrollment: 235
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of days necessary to obtain the result of cCMV infection diagnosis and the audiological result after formal assessment
timeFrame: 1 month
Secondary outcomes:
measure: Measurement of CMV by quantitative PCR
timeFrame: 4 months
measure: Number of children for whom the result of the formal audiological assessment has been obtained
timeFrame: 4 months
measure: Number of children with cCMV infection and confirmed hearing loss in whom antiviral therapy has been initiated within the first month of life
timeFrame: 4 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker-Enfants-Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marianne Leruez-Ville, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fourgeaud J, Boithias C, Walter-Nicolet E, Kermorvant E, Couderc S, Parat S, Pol C, Mousset C, Bussieres L, Guilleminot T, Ville Y, Nkam L, Grimaldi L, Parodi M, Leruez-Ville M. Performance of Targeted Congenital Cytomegalovirus Screening in Newborns Failing Universal Hearing Screening: A Multicenter Study. Pediatr Infect Dis J. 2022 Jun 1;41(6):478-481. doi: 10.1097/INF.0000000000003474. Epub 2022 Jan 27.