Prognostic Value of Neonatal Markers for the Development of Neurosensorial Sequelae in Children Infected by Cytomegalovirus in Utero (CYMEPEDIA)
Primary Purpose
Congenital Cytomegalovirus Infection
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
detection of CMV
Sponsored by
About this trial
This is an interventional diagnostic trial for Congenital Cytomegalovirus Infection focused on measuring Cytomegalovirus, congenital, handicap
Eligibility 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
Sites / Locations
- Hôpital Necker Enfants Malades
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
detection of CMV
Arm Description
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
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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
Prognosis value of antenatal imaging
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
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
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
Screening of congenital CMV infection in a population of 10,000 consecutive newborns in 2 French maternities
Full Information
NCT ID
NCT01923636
First Posted
August 13, 2013
Last Updated
June 10, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01923636
Brief Title
Prognostic Value of Neonatal Markers for the Development of Neurosensorial Sequelae in Children Infected by Cytomegalovirus in Utero
Acronym
CYMEPEDIA
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 9, 2013 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
May 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Cytomegalovirus Infection
Keywords
Cytomegalovirus, congenital, handicap
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
254 (Actual)
8. Arms, Groups, and Interventions
Arm Title
detection of CMV
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
detection of CMV
Intervention Description
Clinical, radiological and laboratory (virological and immunological) standardized reports
Primary Outcome Measure Information:
Title
Prognostic value of neonatal markers (clinical, imaging and biological) for the development of neurosensorial sequelae at 1 year of age
Description
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).
Time Frame
One year
Secondary Outcome Measure Information:
Title
to evaluate the prevalence of congenital CMV in France:
Description
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
Time Frame
At birth
Title
Prognosis value of antenatal imaging
Description
To compare neurodevelopmental and sensorineural sequelae at one year with the result of antenatal imaging (ultrasound and MRI)
Time Frame
one year
Title
Prognostic value of the periodic measurement of the kinetics of viral load shedding
Description
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
Time Frame
One year
Title
neurodevelopmental and sensorineural sequelae according to the type of maternal infectionsequelae
Description
Compare the proportion of neurodevelopmental and sensorineural sequelae according to the type of maternal infection (primary or secondary).
Time Frame
One year
Title
Prevalence and description of congenital CMV infection in 10,000 French neonates
Description
Screening of congenital CMV infection in a population of 10,000 consecutive newborns in 2 French maternities
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence Bussieres, MD
Organizational Affiliation
APHP
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Necker Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
28419213
Citation
Leruez-Ville M, Magny JF, Couderc S, Pichon C, Parodi M, Bussieres L, Guilleminot T, Ghout I, Ville Y. Risk Factors for Congenital Cytomegalovirus Infection Following Primary and Nonprimary Maternal Infection: A Prospective Neonatal Screening Study Using Polymerase Chain Reaction in Saliva. Clin Infect Dis. 2017 Aug 1;65(3):398-404. doi: 10.1093/cid/cix337.
Results Reference
result
PubMed Identifier
32339337
Citation
Leruez-Ville M, Ren S, Magny JF, Jacquemard F, Couderc S, Garcia P, Maillotte AM, Benard M, Pinquier D, Minodier P, Astruc D, Patural H, Ugolin M, Parat S, Guillois B, Garenne A, Parodi M, Bussieres L, Stirnemann J, Sonigo P, Millischer AE, Ville Y. Accuracy of prenatal ultrasound screening to identify fetuses infected by cytomegalovirus which will develop severe long-term sequelae. Ultrasound Obstet Gynecol. 2021 Jan;57(1):97-104. doi: 10.1002/uog.22056.
Results Reference
derived
PubMed Identifier
30596974
Citation
Faure-Bardon V, Magny JF, Parodi M, Couderc S, Garcia P, Maillotte AM, Benard M, Pinquier D, Astruc D, Patural H, Pladys P, Parat S, Guillois B, Garenne A, Bussieres L, Guilleminot T, Stirnemann J, Ghout I, Ville Y, Leruez-Ville M. Sequelae of Congenital Cytomegalovirus Following Maternal Primary Infections Are Limited to Those Acquired in the First Trimester of Pregnancy. Clin Infect Dis. 2019 Oct 15;69(9):1526-1532. doi: 10.1093/cid/ciy1128.
Results Reference
derived
Learn more about this trial
Prognostic Value of Neonatal Markers for the Development of Neurosensorial Sequelae in Children Infected by Cytomegalovirus in Utero
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