Observational study of the management of infants with congenital CMV
Research type
Research Study
Full title
Observational study of the management of infants with congenital CMV
IRAS ID
297135
Contact name
Laura Ferraras-Antolin
Contact email
Sponsor organisation
St George's, University of London and St George's University Hospitals NHS Foundation Trust
Duration of Study in the UK
9 years, 11 months, 30 days
Research summary
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).Infants with cCMV may or may not need treatment with antiviral medication (valganciclovir) depending on whether they show symptoms at birth. The medication has relatively common, but usually reversible, short term side effects but significant hypothetical long term side effects (including cancer and infertility). In addition, the long term hearing and neurodevelopmental outcomes of infants not treated at birth are not well established.
Due to the relatively small numbers of children who present with cCMV in developed
countries, it is important to collaborate between centres to build up enough cases in order to inform practice. This study seeks to build a database of children at multiple centres in the UK who have been diagnosed with symptomatic (receiving treatment) or asymptomatic (no treatment, but have ongoing follow up) cCMV. The data collected for the study will be that collected from routine clinical care from infants with congenital CMV whose parents consent. The data will also contribute to a larger European study.This study aims to follow up infants and children with congenital CMV for up to 6 years from diagnosis (the usual time routine clinical follow up is ongoing for infants diagnosed with cCMV) to assess hearing and neurodevelopmental outcomes and any longer term side effects of medication.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
22/SW/0043
Date of REC Opinion
30 Mar 2022
REC opinion
Further Information Favourable Opinion