Recipient organisationNIHR Great Ormond Street Biomedical Research Centre
NIHR supportRecorded as supported by this research centre
PeriodMar 2025 — Mar 2025
In plain English
AI plain-English summary
Around 90% of babies born with congenital cytomegalovirus (cCMV) show no symptoms at birth, yet the infection remains the leading cause of deafness in newborns and children up to four years old. This study tracks up to 90 people—20 in the UK, the rest in the US—who were treated as infants with antiviral drugs (ganciclovir or valganciclovir) for cCMV, to see whether those medicines have any long-term effects on hearing, brain development, or sexual maturity. The problem is a gap in knowledge. Doctors know the drugs can control the active virus, but no one has systematically followed treated children into adolescence and adulthood to check for delayed consequences. Without that data, clinicians cannot fully weigh the risks and benefits of treating asymptomatic babies. If this study finds that the antivirals cause no lasting harm, it would strengthen the case for wider screening and early treatment of cCMV—potentially preventing thousands of cases of childhood deafness and learning disability. If it uncovers problems, it would guide safer dosing or alternative therapies. Either way, the results will directly inform paediatric treatment guidelines on both sides of the Atlantic.
View original technical description
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.
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