RecruitingOBSERVATIONAL

Prevention Strategy for Respiratory Syncytial Virus (RSV) Infections in Infants in France

This study in France aims to understand how pregnant women decide to protect their newborns from Respiratory Syncytial Virus (RSV), a common winter infection that can make babies very sick. There are two main ways to offer protection: a vaccine for the mother during pregnancy (called Abrysvo®) or a special injection for the baby soon after birth (called nirsevimab or Beyfortus®). Researchers want to find out which method more women choose and why. They will also look at why some women might not choose either option. The goal is to gather information that can help improve future health advice for families.

At a glance

Status

Recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

400

Start

17 Jun 2025

Estimated completion

17 Dec 2025

RSV Infection

What is this study about?

You might have heard about RSV, a common cold-like virus that can be serious for babies and young children, especially during the winter months. It often causes a chest infection called bronchiolitis, which can sometimes lead to babies needing hospital care. Every winter, a lot of babies in Europe get RSV, and it puts a strain on children's hospitals.

Up until recently, ways to protect babies from RSV were quite limited. However, new options have become available. Now, in France, pregnant women have choices to help protect their babies. One option is a vaccine called Abrysvo® that the mother can have during pregnancy. This vaccine helps the mother make protective substances (antibodies) that pass to her baby before birth, protecting them for the first few months of life. The other option is a special injection for the baby called nirsevimab (Beyfortus®) given shortly after birth, which also provides protection against RSV. Both aim to prevent severe RSV infections.

This study is important because these new protection methods are quite new, and doctors don't yet know how many pregnant women in France are choosing them, or why they pick one method over the other. The study will ask women who have recently given birth about their choices regarding RSV prevention. The information gathered will help health services understand what's working well and how to best support families in protecting their babies from RSV in the future.

Key takeaways

This study focuses on RSV protection for babies.
It aims to understand why pregnant women choose certain protection methods.
Participation involves completing a questionnaire.
There are no medical procedures for you or your baby in this study.
Your input will help improve future health advice.

Who may be eligible?

To join this study, you need to be at least 18 years old and able to understand and speak French well enough to read the study information and fill out a questionnaire.

You must also be giving birth in mainland France between October 1, 2024, and January 31, 2025. Your baby needs to be born alive and at full term (meaning 37 weeks of pregnancy or more).

You won't be able to take part if you are under legal protection, for example, if a court has appointed someone to manage your affairs.

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.

Are you 18 years old or older?
Can you understand and speak French well?
Are you giving birth in mainland France between October 2024 and January 2025?
Will your baby be born at 37 weeks or more (full term) and alive?
Are you not under any legal protection (like having a guardian)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your involvement would be quite straightforward. You would be asked to complete a questionnaire. This questionnaire will ask about your choices regarding RSV protection for your baby – whether you had the maternal vaccine, your baby received the injection, or neither – and the reasons behind your decision. There are no clinic visits, medical procedures, or medication to take as part of this study.

Potential risks and benefits

There are no direct medical risks or benefits to you or your baby from taking part in this study, as it only involves completing a questionnaire. The potential benefit is that your experiences will help doctors and health services better understand how to protect babies from RSV in the future. You are free to withdraw from the study at any time without giving a reason, and it will not affect your medical care.

Locations (1)

Public health department, Hôpital Pitié Salpêtrière
Verified postcode
Paris, France· Recruiting

Common questions

What is RSV?

RSV is a common virus that can cause cold-like symptoms but can sometimes lead to serious chest infections, especially in young babies.

Is this study about a new medicine?

No, this study isn't testing a new medicine. It's looking at people's choices about existing ways to protect babies from RSV.

Do I have to do anything to my baby for this study?

No, your baby won't be involved in any procedures for this study. It's about your choices as a mother.

How long will it take to complete the questionnaire?

The study brief does not specify the exact time, but questionnaires are usually designed to be completed in a reasonable amount of time, typically less than an hour.

Will my answers be kept private?

Yes, all information you provide will be treated with strict confidence and used only for research purposes.

How to find out more

Bénédicte COULM, RM,PhD

benedicte.coulm@aphp.fr 01 84 82 85 34 Official trial record

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