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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01923636
Other study ID # P120114
Secondary ID AOM12196
Status Completed
Phase N/A
First received
Last updated
Start date September 9, 2013
Est. completion date May 16, 2022

Study information

Verified date June 2022
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 254
Est. completion date May 16, 2022
Est. primary completion date January 30, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Month
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
detection of CMV
Clinical, radiological and laboratory (virological and immunological) standardized reports

Locations

Country Name City State
France Hôpital Necker Enfants Malades Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Leruez-Ville M, Magny JF, Couderc S, Pichon C, Parodi M, Bussières 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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 1 week
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