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Completed

NCT Number: NCT01923636

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

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.

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Key information

Conditions

Congenital Cytomegalovirus Infection Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

1 day–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Necker Enfants Malades

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

detection of CMV

Other

Clinical, radiological and laboratory (virological and immunological) standardized reports

Primary outcomes

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

    Time frame: 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 outcomes

  1. to evaluate the prevalence of congenital CMV in France:

    Time frame: 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

  2. Prognosis value of antenatal imaging

    Time frame: one year

    To compare neurodevelopmental and sensorineural sequelae at one year with the result of antenatal imaging (ultrasound and MRI)

  3. 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 old for the occurrence of neurodevelopmental and sensorineural sequelae

  4. neurodevelopmental and sensorineural sequelae according to the type of maternal infectionsequelae

    Time frame: One year

    Compare the proportion of neurodevelopmental and sensorineural sequelae according to the type of maternal infection (primary or secondary).

  5. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study 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.

Acronym: CYMEPEDIA

Important dates

Study start
2013
Primary completion
2021
Study completion
2022
First posted
Aug 15, 2013
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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