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

Congenital Cytomegalovirus Infection Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01923636
• Other study ID #: P120114
• Secondary ID: AOM12196
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Congenital Cytomegalovirus Infection
• Cytomegalovirus Infections

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