CompletedObservational

Study on children treated for CMV infection at birth

This study is investigating the long-term health of children who were treated for cytomegalovirus (CMV) infection when they were babies. CMV is a virus that can pass from mothers to babies during pregnancy and can sometimes cause problems like hearing loss or learning difficulties. Some children with CMV at birth received antiviral medicines like Ganciclovir or Valganciclovir. This study wants to see how these medicines affected their hearing, learning, physical development, and general health over time. It's for children aged 2 to 15 who had these treatments. The study won't provide new treatments, but it will help doctors understand the effects of past treatments, which could improve care for future babies with CMV.

At a glance

Status

Completed

Sponsor

University of Oxford

Enrolment target

Start

02 Jan 2025

Estimated completion

31 Mar 2025

Congenital cytomegalovirus (CMV) infection

What is this study about?

This study is about a condition called congenital cytomegalovirus, or cCMV for short. This is an infection that some babies get from their mother during pregnancy. While most babies with cCMV don't have problems, for some, the virus can cause issues like hearing loss, which can show up immediately or later in childhood. It’s also known to be a common viral cause of learning difficulties in children. Because of these potential problems, some babies born with cCMV receive treatment with special medications called antivirals, specifically Ganciclovir or Valganciclovir.

The main aim of this research is to understand the long-term impact of these antiviral treatments. The study wants to explore how these medicines affected children's hearing and overall development – things like their memory, speech, problem-solving, and movement skills – as they grew up. Researchers also want to check the long-term safety of these drugs. By looking back at how children have done, the study aims to gather important information that could help doctors decide on the best care for babies with cCMV in the future.

It’s important to know that this is a 'natural history study'. This means the study won't be giving out any new treatments for cCMV. Instead, it’s focusing on children who were treated in the past. The information gathered will be used to learn from past experiences and help improve treatment approaches for children with cCMV in the years to come.

Key takeaways

This study is for children aged 2-15 who were treated for CMV as babies.
It aims to understand the long-term effects of past antiviral treatments on hearing and development.
Your child will have health checks, hearing tests, and learning assessments.
Blood, urine, saliva samples, and a wrist X-ray will be collected.
There are no new treatments given; it's about learning from past care.
Participation could help improve care for future babies with CMV.

Who may be eligible?

This study is looking for children aged between 2 and 15 years old. This means your child must be at least 2 years old but not yet 16 years old.

To be included, your child must have been previously treated for congenital CMV infection with either intravenous ganciclovir (given through a vein) or oral valganciclovir (taken by mouth). This treatment must have been given by doctors at one of the hospitals participating in the Collaborative Antiviral Study Group.

Your child won't be able to take part if they are unable to follow the study's instructions or complete the assessments.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child aged between 2 and 15 years old?
Was your child treated for congenital CMV infection as a baby?
Did they receive either Ganciclovir (into a vein) or Valganciclovir (by mouth) for this?
Was this treatment given at a hospital that was part of the Collaborative Antiviral Study Group?
Is your child able to come to appointments and complete study assessments?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, it will involve several steps. First, you'll be asked questions about your child's medical history. The researchers will also look at some information from your child's existing medical records. Your child will have a physical examination, and various tests will be carried out.

These tests include what's called a neurodevelopmental assessment. This involves checking your child's memory, how they speak, their problem-solving skills, their movement skills, and how well they listen. They will also have a hearing assessment to check their hearing. The study will also collect small samples of your child's urine, saliva (spit), and blood. Finally, a picture (X-ray) of your child's left wrist will be taken to estimate their bone age.

The study is expected to run from October 2024 to April 2025.

Potential risks and benefits

There may not be a direct personal benefit to your child from taking part in this study. However, the information gathered could be very helpful for guiding future research into how babies with congenital CMV are treated, potentially benefiting many other children. There are some potential risks: the physical exam includes checks that some children might find uncomfortable. Giving a saliva sample might also be a little uncomfortable. Taking a blood sample can cause a small sting or bruising, and very rarely, an infection. An X-ray of the wrist involves a very small amount of radiation, similar to what we experience daily from the natural environment in less than 3 hours. While the chance of harm from this is very low, it's an extra exposure your child wouldn't otherwise have. You are free to withdraw your child from the study at any time.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Oxford University Hospitals NHS Foundation Trust
City only
Oxford, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
City only
Newcastle upon Tyne, United Kingdom
Great Ormond Street Hospital for Children NHS Foundation Trust
City only
London, United Kingdom
St George's University Hospitals NHS Foundation Trust
City only
London, United Kingdom

Common questions

What is CMV infection?

CMV (cytomegalovirus) is a common virus. Congenital CMV means a baby caught the virus from their mother during pregnancy. For some babies, it can cause health problems.

What kind of treatments are being looked at?

The study is looking at two antiviral medicines, Ganciclovir and Valganciclovir, which some children received for their CMV infection when they were babies.

Will my child receive any new medication in this study?

No, this study is about looking at the long-term effects of treatments your child received in the past. No new treatments will be given.

How long will my child need to be involved?

The study runs from October 2024 to April 2025. Your specific involvement will include various assessments and tests during this period.

Who is paying for this study?

The study is funded by the National Institutes of Health (NIH) in the USA, through the University of Alabama in Birmingham (UAB).

How to find out more

Simon Drysdale

childrensresearch@paediatrics.ox.ac.uk +44 (0)1865 2 27503 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.