Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Congenital Cytomegalovirus Infection Other: detection of CMV Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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

  4. 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).

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

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


Locations
Layout table for location information
France
Hôpital Necker Enfants Malades
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Study Director: Laurence Bussieres, MD APHP

Publications of Results:
Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01923636     History of Changes
Other Study ID Numbers: P120114
AOM12196
First Posted: August 15, 2013    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cytomegalovirus, congenital, handicap
Additional relevant MeSH terms:
Layout table for MeSH terms
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases