Prognostic Value of Neonatal Markers for the Development of Neurosensorial Sequelae in Children Infected by Cytomegalovirus in Utero

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Prognostic Value of Clinical, Imaging, Immunological and Virological Markers in the Neonatal Period for the Development of Neurosensorial Sequelae at 1 Year in Children Infected by Cytomegalovirus in Utero.

Conditions
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Congenital Cytomegalovirus Infection

Intervention / Treatment
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* Other: detection of CMV


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: detection of CMV<br>Cohort of neonates 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 | Other: detection of CMV<br>* Clinical, radiological and laboratory (virological and immunological) standardized reports<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognostic value of neonatal markers (clinical, imaging and biological) for the development of neurosensorial sequelae at 1 year of age | 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). | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the prevalence of congenital CMV in France: | 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 | At birth | 
| Prognosis value of antenatal imaging | To compare neurodevelopmental and sensorineural sequelae at one year with the result of antenatal imaging (ultrasound and MRI) | one year | 
| Prognostic value of the periodic measurement of the kinetics of viral load shedding | 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 | One year | 
| neurodevelopmental and sensorineural sequelae according to the type of maternal infectionsequelae | Compare the proportion of neurodevelopmental and sensorineural sequelae according to the type of maternal infection (primary or secondary). | One year | 
| Prevalence and description of congenital CMV infection in 10,000 French neonates | Screening of congenital CMV infection in a population of 10,000 consecutive newborns in 2 French maternities | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cytomegalovirus, congenital, handicap