Observational Study of the Management of Infants With Congenital CMV
ConditionCongenital Cmv
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 10
SponsorSt George's, University of London
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Refusal to sign written informed consent of parents/ legal guardian.
Trial population
Children will be identified at their routine healthcare attendance at the specialist clinics for children with congenital CMV at one of the participating centres. The person with parental responsibility will be approached to be informed about the registry and to request consent, either by the cCMVNET clinician or a delegated research nurse.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Measuring cases of cCMV in the UK
To analyze the epidemiology of children born with cCMV
Time frame
15 years2
Clinical characteristics
To analyze the clinical characteristic of children born with cCMV (measure is number of participants with hearing loss, retinitis, neurological abnormalities, skin rashes, or hepatosplenomegaly)
Time frame
15 years3
To evaluate risk factors in children with cCMV for long term sequelae
To measure the number of cases with abnormal brain imaging (cranial USS or MRI), hearing loss, retinitis or anaemia, leucopenia, thrombocytopenia, renal function or liver abnormalities at diagnosis
Time frame
15 years4
Adverse events
To document adverse events of different treatment strategies
Time frame
15 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
St George's, University of London
Lead sponsor
European Society for Paediatric Infectious Diseases
Collaborator
Source ClinicalTrials.gov