Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Randomized, multicenter, open-label study on PREvention of respiratory SEquelae of RSV bronchiolitis in preterm babies (PRESERV)

This research study, called PRESERV, is for premature babies who have had a chest infection from RSV (Respiratory Syncytial Virus). RSV can sometimes lead to lasting breathing problems like wheezing or even asthma. Doctors want to find out if a medicine called Synagis can help prevent these long-term breathing issues. Half the babies in the study will receive Synagis injections, and the other half won't. Researchers will then compare how many breathing problems, like future chest infections or recurrent wheezing, each group experiences during their first year. The study also looks at how many times babies need to go to the hospital because of RSV and the costs involved for the NHS and families.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Azienda Sanitaria Locale Della Provincia Di Biella

Enrolment target

760

Start

07 Aug 2024

Respiratory sincizial (RSV) bronchiolitis

What is this study about?

This study is called PRESERV, and it's looking into ways to protect premature babies who have had a common chest infection caused by RSV. RSV is a very common virus, especially in young children, and it can cause a chesty cough and breathing difficulties, a condition known as bronchiolitis. While most children recover fully, premature babies can sometimes be more vulnerable and develop ongoing breathing issues, such as repeated wheezing or even asthma, later on.

The main aim of this study is to see if a specific medicine, Synagis (also known by its active ingredient, palivizumab), can help prevent these long-term breathing problems. Synagis is a special antibody that can help protect babies from severe RSV infections. In this study, some babies will receive Synagis injections, and others won't. Doctors will then closely watch both groups of babies for about a year to see if the medicine makes a difference.

They'll be carefully counting things like how often a baby gets chest infections, how many days they might wheeze, or if they need medicines for wheezing. The study also aims to understand the impact on families and the healthcare system, looking at things like hospital stays and costs. By carefully comparing the two groups, researchers hope to learn if Synagis can significantly improve the breathing health of premature babies after an RSV infection.

Key takeaways

The study is for premature babies who have had a chest infection from RSV.
It tests if a medicine called Synagis can prevent future breathing problems like wheezing or asthma.
Babies will either receive Synagis injections or no specific RSV preventive medicine.
Researchers will monitor babies' breathing health for about one year.
Participation helps us understand the best care for premature babies.
You can withdraw your baby at any time without affecting their care.

Who may be eligible?

This study is looking for premature babies who have recently had a chest infection caused by the RSV virus. Premature means babies born before their due date.

Both baby boys and baby girls can join the study. There are no specific age limits apart from being premature and having had RSV bronchiolitis. If your baby fits this description, they might be able to take part.

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 premature (born early)?
Has your baby recently had a chest infection (bronchiolitis) caused by the RSV virus?
Are you able to bring your baby to regular clinic appointments?
Are you happy for your baby to potentially receive a study medicine or no intervention for RSV prevention?

Answer every question to see your result.

What does participation involve?

If your baby takes part in this study, they will either receive a regular injection of the study medicine, Synagis, or no extra medicine for RSV prevention. It's a 'randomised' study, meaning a computer will decide which group your baby is in, and neither you nor your doctor will get to choose.

You'll need to attend regular clinic visits with your baby. During these visits, doctors will check your baby's health, ask about any breathing issues, and record any hospital stays. Your baby will have regular assessments, and the Synagis injections (if in that group) will be given during some of these visits. The study will follow your baby for about a year to see how their breathing health develops.

Potential risks and benefits

Taking part in any study has potential benefits and potential risks. A potential benefit of this study is that your baby might receive a medicine that could help prevent future breathing problems. There's also the benefit of contributing to medical knowledge that could help other premature babies in the future. Potential risks might include minor side effects from the Synagis injection, like a sore arm, or the stress of additional clinic visits. All medicines have potential side effects, which will be fully explained. Remember, you can choose to withdraw your baby from the study at any time, for any reason, without affecting their usual medical care.

Locations (1)

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

—
Unverified
Italy

Common questions

What is RSV?

RSV (Respiratory Syncytial Virus) is a common virus that causes cold-like symptoms, but in young babies, especially premature ones, it can cause more serious chest infections called bronchiolitis.

What is Synagis?

Synagis is a special medicine given as an injection. It contains antibodies that help protect babies from getting very sick if they catch the RSV virus.

Will my baby definitely get Synagis?

No, because it's a 'randomised' study, a computer decides if your baby gets Synagis or not. Half the babies get Synagis, and half don't, so doctors can compare the results.

What will doctors be looking for?

Doctors will be looking to see if babies who received Synagis have fewer chest infections, less wheezing, or are less likely to develop asthma compared to those who didn't.

How long will my baby be in the study?

Your baby will be followed in the study for about one year after they join.

How to find out more

Official trial record

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