NCT05855889

Observational Study of the Management of Infants With Congenital CMV

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: St George's, University of London · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2023-03-09
• Primary completion: 2031-03-30
• Completion: 2038-03-30
• First posted: 2023-05-12
• Last updated: 2023-05-23

Locations

1 site across 1 country: United Kingdom