RecruitingOBSERVATIONAL

Observational Study of the Management of Infants With Congenital CMV

This study is gathering information on how babies born with a common infection, called congenital CMV (cCMV), are looked after. This infection can affect health, including hearing. We want to understand what care and treatments lead to the best outcomes for these children. By carefully observing their journey, we hope to find ways to improve their care in the future. This is a worldwide study, and we're simply collecting information from children's existing medical records and follow-up appointments. No new tests or treatments will be given as part of the study; it's all about understanding current care practices. This will help doctors make better decisions for future children with cCMV.

At a glance

Status

Recruiting

Sponsor

St George's, University of London

Enrolment target

200

Start

09 Mar 2023

Estimated completion

30 Mar 2038

Congenital Cmv

What is this study about?

This study is about a common infection called Cytomegalovirus, or CMV, which some babies are born with. When a baby gets this infection during pregnancy, it's called congenital CMV (cCMV). While many babies with cCMV don't have any problems, for some, it can lead to health issues, including hearing loss or developmental delays. Because it's often hard to spot this infection during pregnancy or right after birth, doctors are still learning the best ways to manage and treat it, and who benefits most from which approaches.

This study isn't about trying new medicines or tests. Instead, it's an 'observational' study. This means doctors are simply watching and collecting information about how children with cCMV are currently being cared for in different hospitals. They'll look at their medical records and follow their progress over time, typically until around age 6, or longer if needed. The goal is to see which types of care and treatments are linked to the best results for these children. This information will be combined with data from other countries to get a bigger picture.

By gathering all this information, researchers hope to understand more about cCMV and how different approaches to care affect a child's health and development. This will help doctors develop better guidelines and give more effective care to babies born with cCMV in the future, improving their chances for a healthy life. Your child's participation would simply involve allowing their routine medical information to be shared for this important research.

Key takeaways

This study is about learning more about congenital CMV (cCMV) in babies.
It's an 'observational' study, meaning no new treatments or tests.
Information is collected from your child's existing medical records and check-ups.
The aim is to improve care for children with cCMV in the future.
Your child's participation is safe and confidential.
You can withdraw your child at any time without affecting their care.

Who may be eligible?

This study is looking for children who have been diagnosed with congenital CMV (cCMV).

Your child would be eligible if they are under 11 years old and their cCMV diagnosis was confirmed by specific tests (like checking for the virus in their pee, spit, blood, or from a dried blood spot from when they were a baby) within the first 21 days of life, or from their umbilical cord blood. Sometimes, cCMV is diagnosed later in childhood, and these children could also be included.

The most important thing is that parents or legal guardians are happy for their child to take part and give their written permission.

Quick self-check

Is your child under 11 years old?
Was your child diagnosed with congenital CMV (cCMV)?
Was their cCMV confirmed by specific tests (e.g., in their pee, spit, blood, or umbilical cord blood)?
Are you, as a parent or guardian, willing to give written permission for your child's medical information to be used?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study is very straightforward, as it's an 'observational' study. This means your child won't receive any special treatments, tests, or investigations beyond their usual care. Instead, the study will collect information from your child's existing medical records. This includes details about their diagnosis, any treatments they receive, and their follow-up appointments with different specialists like infectious disease doctors, hearing specialists, eye doctors, and developmental experts. These follow-up appointments are a normal part of care for children with cCMV and usually continue until they are about 6 years old, or longer if there are ongoing health concerns. There are no extra visits or appointments required for this study, and the information is simply gathered from the care they are already receiving.

Potential risks and benefits

There are no direct risks to your child from taking part in this study, as no new treatments or tests are involved. All information collected will be handled confidentially. The main benefit is that the information gathered from your child's medical journey, combined with others, will help doctors learn more about cCMV and improve care for other children in the future. You have the right to withdraw your child from the study at any time, without giving a reason, and this will not affect their medical care.

Locations (1)

St George's University of London
London, United Kingdom· Recruiting

Common questions

What is CMV?

CMV (Cytomegalovirus) is a common virus. When a baby gets it before birth, it's called congenital CMV (cCMV). Most people with CMV don't have symptoms, but it can sometimes cause health problems in babies born with it.

Will my child get new medicines or treatments in this study?

No, this study is 'observational', meaning it only gathers information from the regular care your child is already receiving. No new medicines, treatments, or tests will be given as part of this study.

How long will my child be part of the study?

The study will collect information about your child's care and progress over time, typically until they are around 6 years old, matching their routine follow-up schedule.

Will my child's information be kept private?

Yes, all information collected for the study will be handled carefully and confidentially to protect your child's privacy.

What is the main goal of this study?

The main goal is to understand which types of care and treatments for cCMV lead to the best results for children, so that doctors can improve care for all children with this condition in the future.

How to find out more

Sana Ibrahim, BSc

sibrahim@sgul.ac.uk +44 (0)208 725 5382 Official trial record

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