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

NCT01923636 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2025-09-05

No results posted yet for this study

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.

Conditions

  • Congenital Cytomegalovirus Infection

Interventions

OTHER

detection of CMV

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

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Laurence Bussieres, MD · APHP

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-09
Primary Completion
2021-01-30
Completion
2022-05-16

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01923636 on ClinicalTrials.gov