Prognostic Value of Neonatal Markers for the Development of Neurosensorial Sequelae in Children Infected by Cytomegalovirus in Utero (CYMEPEDIA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01923636|
Recruitment Status : Active, not recruiting
First Posted : August 15, 2013
Last Update Posted : July 11, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Congenital Cytomegalovirus Infection||Other: detection of CMV||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||260 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Actual Study Start Date :||September 9, 2013|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||December 31, 2020|
detection of CMV
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
Clinical, radiological and laboratory (virological and immunological) standardized reports
- Prognostic value of neonatal markers (clinical, imaging and biological) for the development of neurosensorial sequelae at 1 year of age [ Time Frame: 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).
- to evaluate the prevalence of congenital CMV in France: [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 week ]Screening of congenital CMV infection in a population of 10,000 consecutive newborns in 2 French maternities
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923636
|Hôpital Necker Enfants Malades|
|Paris, France, 75015|
|Study Director:||Laurence Bussieres, MD||APHP|