Observational study on managing infants with congenital CMV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather data on infants diagnosed with congenital cytomegalovirus (cCMV) through a multicenter cohort approach. It will track these patients from various clinical perspectives, including infectious diseases, audiology, ophthalmology, and neurodevelopment, until they are approximately six years old. The study will not involve any additional investigations or treatments beyond standard clinical practice, and it will also include some children diagnosed retrospectively. The goal is to identify characteristics associated with patient outcomes to enhance future care.

Why it matters

Who can join: the full rules

Inclusion Criteria: Patients of either sex that have been diagnosed with cCMV infection:

* 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 Criteria:

* Refusal to sign written informed consent of parents/ legal guardian.

Where it's running

• St George's University of London
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Simon Drysdale, MD — St George's, University of London
• Study coordinator: Sana Ibrahim, BSc
• Email: sibrahim@sgul.ac.uk
• Phone: +44 (0)208 725 5382

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.