Observational Study of the Management of Infants With Congenital CMV
St George's, University of London
200 participants
Mar 9, 2023
OBSERVATIONAL
Conditions
Summary
This is an observational, prospective/retrospective multicentre, cohort study of children diagnosed with cCMV. This study will contribute to a wider study also recruiting participants in Europe and other countries worldwide. No investigations or treatment will be carried out that are not part of routine clinical practice. Infants with cCMV are routinely followed up from an infectious diseases, audiology, ophthalmology and neurodevelopmental perspective until approximately 6 years of age, or longer if there are ongoing issues. Some children will be retrospectively diagnosed with cCMV in later childhood. Recruitment can be from any centre that manages these patients and has agreed to participate in the study.
Eligibility
Inclusion Criteria5
- Through confirmed detection of CMV in urine or saliva, by CMV-DNA PCR (or viral culture / Shell-vial) and/or CMV detection in blood or CSF by PCR within the first 21 days of life.
- Children with cCMV retrospectively diagnosis by positive CMV-DNA PCR in dried blood spots (DBS), collected within 21 days of life.
- Diagnosed by positive CMV-DNA PCR in dried umbilical cord blood or donated/stored umbilical cord blood sample
- Children whose parents give their informed consent to participate in the study
- Age less than 11 years old
Exclusion Criteria1
- Refusal to sign written informed consent of parents/ legal guardian.
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05855889