cCMV Retrospective Follow-Up Study
Research type
Research Study
Full title
A RETROSPECTIVE FOLLOW-UP STUDY OF THE DURABILITY OF ANTIVIRAL THERAPY ON LONG-TERM HEARING AND NEURODEVELOPMENTAL OUTCOMES AMONG PATIENTS TREATED FOR CONGENITAL CYTOMEGALOVIRUS INFECTION AS INFANTS OR TODDLERS
IRAS ID
341389
Contact name
Simon Drysdale
Contact email
Sponsor organisation
University of Oxford/ Research Governance, Ethics and Assurance
Duration of Study in the UK
0 years, 8 months, 31 days
Research summary
Congenital cytomegalovirus (cCMV) infection is a rare infection that occurs when the cytomegalovirus virus is transferred from the mother to the baby during pregnancy or childbirth. It is the leading cause of deafness in newborns and children up to 4 years old. Only 10 out of 100 babies with cCMV have symptoms at birth, which is called symptomatic cCMV. Babies showing symptoms of this infection will be tested for the disease. The remaining 90% of babies have no symptoms of CMV at birth. These babies are called asymptomatic cCMV. The majority of children with deafness caused by cCMV are part of the asymptomatic group. cCMV is also the most frequently identified viral cause of general learning disability in children.
This study will run in parallel in the UK and the USA. The UK aims to recruit up to 20 participants and data will be combined with the USA participants to a total of 90. The study will recruit participants with cCMV (with or without symptoms) who have previously been treated with an antiviral medication (ganiciclovir or Valganciclovir). These participants will be recruited from multiple research facilities in the US and the UK who are part of the Collaborative Antiviral Study Group (CASG). The purpose of the study is to find out if there is any long-term impact on hearing, overall neurodevelopment, and sexual maturity development in patients who received these medicines to treat cCMV in the past. To do participants will have some tests such done as a blood test, hearing test and an assessment of neurodevelopment. Participants will not receive any medications.
REC name
HSC REC B
REC reference
24/NI/0136
Date of REC Opinion
21 Nov 2024
REC opinion
Further Information Favourable Opinion