Observational Study of the Management of Infants With Congenital CMV

NCT ID: NCT05855889

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-09
• Study Completion Date: 2038-03-30

Brief 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.

Detailed Description

Cytomegalovirus (CMV) is the most frequent cause of congenital infection worldwide, occurring in 0.2-2% of live births. It is also the most frequent cause of non-genetic hearing loss, and an important cause of neurodevelopmental delay. Clinical diagnosis of maternal infection during pregnancy is unreliable in most patients and laboratory diagnosis can be challenging, especially in non-primary infections. Screening of congenital CMV infection (cCMV) in newborns is not recommended in most countries and only targeted screening is performed in some cases (children who fail hearing screening or with abnormalities compatible with cCMV in physical exams).

The main focus of the study is to identify patient and treatment characteristics that are associated with outcome. This will allow improved patient care in the future.

Conditions

Congenital Cmv

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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.

• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Society for Paediatric Infectious Diseases

OTHER

Sponsor Role: collaborator

St George's, University of London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon Drysdale, MD

Role: PRINCIPAL_INVESTIGATOR

St George's, University of London

Locations

St George's University of London

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Sana Ibrahim, BSc

Role: CONTACT

sibrahim@sgul.ac.uk

+44 (0)208 725 5382

Facility Contacts

Sana Ibrahim, BSc

Role: primary

sibrahim@sgul.ac.uk

+44 (0)208 725 5382

Other Identifiers

2021.0118

Identifier Type: -

Identifier Source: org_study_id