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

Not Applicable

Completed

• Conditions: Congenital Cytomegalovirus Infection
• Interventions: Other: detection of CMV

• Registration Number: NCT01923636
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2013-08-13
• Study First Submitted QC: 2013-08-13
• Study First Posted: 2013-08-15
• Study Start: 2013-09-09
• Primary Completion: 2021-01-30
• Study Completion: 2022-05-16
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-10
• Last Update Posted: 2022-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
detection of CMV	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

Primary Outcome Measures

Name	Time	Method
Prognostic value of neonatal markers (clinical, imaging and biological) for the development of neurosensorial sequelae at 1 year of age	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

Name	Time	Method
Prognostic value of the periodic measurement of the kinetics of viral load shedding	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
Prognosis value of antenatal imaging	one year	To compare neurodevelopmental and sensorineural sequelae at one year with the result of antenatal imaging (ultrasound and MRI)
neurodevelopmental and sensorineural sequelae according to the type of maternal infectionsequelae	One year	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	1 week	Screening of congenital CMV infection in a population of 10,000 consecutive newborns in 2 French maternities
to evaluate the prevalence of congenital CMV in France:	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

Trial Locations

Locations (1)

Hôpital Necker Enfants Malades; 🇫🇷 Paris, France