CompletedNot Applicable

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

France254 participantsStarted 2013-09-09

Plain-language 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.

Who can participate

Age range1 Day – 1 Month

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: One year

Trial details

NCT IDNCT01923636

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-30

View on ClinicalTrials.gov More Congenital Cytomegalovirus Infection trials