NCT01923636

Prognostic Value of Neonatal Markers for the Development of Neurosensorial Sequelae in Children Infected by Cytomegalovirus in Utero

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 1 Day – 1 Month
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Cytomegalovirus Infection

Interventions

Type	Name	Description
OTHER	detection of CMV	Clinical, radiological and laboratory (virological and immunological) standardized reports

Timeline

• Start date: 2013-09-09
• Primary completion: 2021-01-30
• Completion: 2022-05-16
• First posted: 2013-08-15
• Last updated: 2025-09-05

Locations

1 site across 1 country: France