Clinical Trial: Prognostic Value of Neonatal Markers (Clinical, Imaging and Biological) for the Development of Neurosensorial Sequelae in Children Infected by Cytomegalovirus (CMV) in Utero

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 C

Brief Summary:

The main objective of this study is to elaborate, in the neonatal period, a prognostic score for the development of neurological and sensorineural sequelae at 1 year in neonates infected in utero by cytomegalovirus. This score will be based on clinical, imaging and biological evaluations.

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 10,000 consecutive neonates.


Detailed Summary:

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 them 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.


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Prognostic value of neonatal markers (clinical, imaging and biological) for the development of neurosensorial sequelae at 1 year of age [ Time Frame: One year ]

Neonates included in the study will be evaluated within the first month of life (J0) and at month 4 and month 12. 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Prognosis value of antenatal imaging [ Time Frame: 2 years ]
    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 for the occurrence of neurodevelopmental and sensorineural sequelae
  • Frequency of the occurrence of neurodevelopmental and sensorineural sequelae [ Time Frame: One year ]
    Compare the frequency of occurrence of neurodevelopmental and sensorineural sequelae depending on 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


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: August 13, 2013
Date Started: September 2013
Date Completion: December 2020
Last Updated: December 23, 2016
Last Verified: December 2016