Diagnosis of Congenital Cytomegalovirus Infection in Newborn With Particular Risk
NCT ID: NCT05754879
Last Updated: 2023-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
479 participants
OBSERVATIONAL
2019-02-01
2022-12-31
Brief Summary
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Congenital infection is symptomatic in 10% of cases with a large clinical spectrum with different degree of severity. These sequelae develop progressively and fluctuate, which justifies prolonged follow-up of children for several years, even if they are asymptomatic at birth.
There is yet no treatment with AMM in neonates or pregnant women. In France, screening for congenital CMV infection is widely debated. It remains oriented to certain newborns considered at risk or depending on their symptoms and varies with the practices of each Neonatology or Maternity Hospital.
In the Regional Maternity of Nancy, a new screening protocol for congenital CMV infection was implemented from early 2019.
It is based on screening by non-invasive salivary test (CMV PCR) in newborns at particular risk who are included in a registry open for this screening.
The aim of this research was to assess the relevance of the proposed criteria in the Protocol for defining a population at risk of congenital CMV infection thus qualifying for CMV screening. The secondary endpoints are the modalities of the screening test, the evaluation of each risk factor for infection, and the study of affected patients (symptoms, therapeutic intervention, neurological and auditory outcome).
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Eligibility Criteria
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Inclusion Criteria
* Patients who were screened for congenital CMV infection by salivary PCR
Exclusion Criteria
3 Weeks
ALL
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Jean-Michel HASCOET
Professor
Locations
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Maternity Hospital CHRU
Nancy, , France
Countries
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Other Identifiers
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2022PI027
Identifier Type: -
Identifier Source: org_study_id
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