Congenital Cytomegalovirus Infection
Conditions
Keywords
Cytomegalovirus, congenital, handicap
Brief summary
The main objective of this study is to validate , in the neonatal period, a prognostic score for the development of neurosensorineural sequelae at 1 year and at 2 years in neonates infected in utero by cytomegalovirus. This score will be based on clinical, imaging and biological criteria . The second objective of the study is to estimate the prevalence of this infection in France and to describe its epidemiology through the screening of 12,000 consecutive neonates.
Detailed description
Infection with cytomegalovirus (CMV) is the most frequent cause of congenital neurological handicap of infectious origin in industrialized countries. Around 10% of infected neonates have symptoms and more than 50% of those will develop long term neurological sequelae and sensorineural hearing loss. Among asymptomatic infected neonates 10 to 15% will ultimately develop hearing loss. To establish the prognosis of infected neonates remains difficult and the purpose of the study is to better define early prognosis factors The true burden of CMV congenital infection is unknown in France: the prevalence of the infection as well as the description of its epidemiology (proportion of symptomatic and asymptomatic cases, rate of long term sequelae, proportion of cases following primary or secondary maternal infections) are unknown.
Interventions
OTHERdetection of CMV
Clinical, radiological and laboratory (virological and immunological) standardized reports
Sponsors
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 1 Months
Healthy volunteers
No
Inclusion criteria
Main objective: Neonate less than 1 month with congenital CMV infection at birth objectified by the detection of CMV in a urine sample, in saliva or blood (fresh or Guthrie card) obtained in the first 10 days life * Whose parents accept regular monitoring by the paediatrician investigator * For which a medical examination has been made * Affiliated with a social security system * And whose mother has given its written consent to the participation of their child to study
Exclusion criteria
\- Children participating in an interventional study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prognostic value of neonatal markers (clinical, imaging and biological) for the development of neurosensorial sequelae at 1 year of age | One year | Assessment will include standardised clinical evaluation, cerebral ultrasound, cerebral MRI, audiometric tests, developmental tests, virological tests (viral load in blood and saliva) and immunological tests (cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), Natural Killer (NK) and cytokines). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| to evaluate the prevalence of congenital CMV in France: | At birth | screening by CMV PCR in a saliva sample collected in delivery room will be proposed to all mothers with a live birth neonate born in the Necker or Poissy |
| Prognosis value of antenatal imaging | one year | To compare neurodevelopmental and sensorineural sequelae at one year with the result of antenatal imaging (ultrasound and MRI) |
| Prognostic value of the periodic measurement of the kinetics of viral load shedding | One year | To evaluate the prognostic value of the kinetics of CMV viral load in blood and in saliva from birth to 1 year old for the occurrence of neurodevelopmental and sensorineural sequelae |
| neurodevelopmental and sensorineural sequelae according to the type of maternal infectionsequelae | One year | Compare the proportion of neurodevelopmental and sensorineural sequelae according to the type of maternal infection (primary or secondary). |
| Prevalence and description of congenital CMV infection in 10,000 French neonates | 1 week | Screening of congenital CMV infection in a population of 10,000 consecutive newborns in 2 French maternities |
Countries
France
Outcome results
None listed