RecruitingOBSERVATIONAL

Overview of Targeted Screening for Congenital Infection Guided by Neonatal Hearing Screening

This study is about a new way to check babies for a common infection called Cytomegalovirus (CMV). CMV is the most frequent infection babies are born with and can lead to hearing loss and other health issues, even if the baby seems healthy at birth. Currently, most babies aren't routinely checked for CMV. This study aims to gather information from babies at Strasbourg University Hospitals who have an unusual result on their first hearing screen. Doctors want to see if these babies have CMV and how the infection affects their health over time. The goal is to better understand CMV-related hearing loss and other conditions to improve care for infected babies.

At a glance

Status

Recruiting

Sponsor

University Hospital, Strasbourg, France

Enrolment target

450

Start

16 Jun 2025

Estimated completion

16 Jun 2026

Neonatal Hearing Loss

What is this study about?

This study is looking into a common infection that some babies can be born with, called Cytomegalovirus (CMV). While many people haven't heard of it, CMV is the most frequent infection babies get before they are born. It's an important infection to understand because it's the second most common reason for hearing loss in babies after genetic causes, and it can also cause other developmental problems.

Most babies with CMV infection don't show any signs of it when they are born. However, about 10 to 25 out of every 100 infected babies will have hearing loss at birth or develop it as they get older. This hearing loss can often get worse over time. Currently, there isn't a routine test for all pregnant mothers or newborns to check for CMV.

Finding out if a baby has CMV, especially when they have hearing problems, is very helpful for parents to understand why their child has hearing difficulties. It also allows doctors to provide special care and regular check-ups for the baby's hearing, brain development, and eyes. Since 2018, health experts in France have suggested checking for CMV in babies who don't pass their newborn hearing screening. This study will collect information from babies at Strasbourg University Hospitals who are screened this way, to learn more about how CMV affects them.

Key takeaways

CMV is a common infection babies can be born with.
It's a leading cause of hearing loss in babies.
Many infected babies show no symptoms at birth.
This study looks at checking for CMV in babies who don't pass their hearing test.
Finding CMV early can help guide a baby's medical care and follow-up.
The study aims to improve our understanding of CMV's effects on babies.

Who may be eligible?

This study is looking for very young babies, specifically those between birth and one month old, who have just had their first hearing test.

To be included, your baby must have had an unclear result on their newborn hearing screen, meaning their hearing test showed something unusual in one or both ears and needed a retest which also came back unclear. This applies to babies born between August 2024 and the end of July 2025.

Your baby would not be able to join if a CMV test was done for them after they were one month old and came back positive, or if they had a CMV test for any other reason not related to this study.

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 baby between birth and one month old?
Did your baby have an unclear result on their newborn hearing screen (retest also unclear)?
Was your baby born between August 2024 and July 2025?
Has your baby NOT had a positive CMV test after one month of age?
Has your baby NOT had a CMV test done for reasons other than this study?

Answer every question to see your result.

What does participation involve?

This study is mainly about collecting information from routine medical checks your baby will already be having. If your baby has an unclear result on their newborn hearing screening, doctors will check for CMV infection. If CMV is found, your baby will have further standard medical checks. These usually include a close look at their eyes, another hearing test, brain scans, and blood tests. The study will then gather this information to learn more about CMV and its effects.

Potential risks and benefits

Participating in this study means that if your baby doesn't pass their hearing test, they will be checked for CMV, which could help explain any hearing problems and guide their care. While there are no direct extra medical procedures for this study beyond what your medical team would recommend if CMV is suspected, there are no guaranteed benefits for your baby. The main benefit is to help doctors learn more, which could improve care for future babies. You are always free to decide not to take part in the study, or to withdraw at any time, without it affecting your baby's medical care.

Locations (1)

Service d'ORL et de Chirurgie Cervico-faciale - CHU de Strasbourg - France
Verified postcode
Strasbourg, France· Recruiting

Common questions

What is CMV?

CMV stands for Cytomegalovirus. It's a common virus that can infect anyone, but it can be more serious for babies if they catch it before they are born.

Why is CMV a concern for babies?

CMV can cause problems like hearing loss, which might get worse over time, and can sometimes lead to other developmental issues in babies.

Are all babies checked for CMV?

No, currently, there isn't a routine check for CMV for all pregnant mothers or newborns. This study focuses on babies with unclear hearing tests.

What happens if my baby has CMV?

If your baby is found to have CMV, doctors will provide special care including regular checks of their hearing, eyes, and brain development to ensure they get the best support.

Will my baby get any new treatments in this study?

This study is about collecting information from standard checks and follow-ups. It does not involve new treatments, but helps ensure your baby receives appropriate care if CMV is found.

How to find out more

Carine EYERMANN, MD

carine.eyermann@chru-strasbourg.fr 33 3 88 12 76 56 Official trial record

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