Observational study on managing infants with congenital CMV
Observational Study of the Management of Infants With Congenital CMV
This study is tracking infants with congenital cytomegalovirus to see how their health develops over time and to improve future care for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | N/A to 10 Years |
| Sex | All |
| Sponsor | St George's, University of London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05855889 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include infants diagnosed with cCMV infection through specific laboratory methods within the first 21 days of life.
Not a fit: Patients who do not have a confirmed diagnosis of cCMV or whose parents do not consent to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and outcomes for infants with congenital CMV.
How similar studies have performed: Other studies have shown success in understanding cCMV management, but this specific observational approach may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
London
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.