Active not recruitingOBSERVATIONAL

RESCEU: Defining the Burden of RSV Disease

The RESCEU study is investigating Respiratory Syncytial Virus (RSV) infections in healthy babies in the UK. Over a six-year period, starting now and continuing until November 2026, the study aims to understand how many babies get RSV, how often they need medical help or hospitalisation, and the overall impact of the illness. Researchers will also look at the financial costs and how RSV affects families' quality of life. By collecting information from at least 2000 babies, the study hopes to identify factors that make babies more likely to get RSV and develop more severe illness. This will help doctors and healthcare providers better understand and manage RSV in young children.

At a glance

Status

Active not recruiting

Sponsor

University of Oxford

Enrolment target

2,000

Start

05 Sep 2017

Estimated completion

30 Nov 2026

Respiratory Syncytial Virus Infections RSV Infection

What is this study about?

The RESCEU study is all about understanding a common winter bug called Respiratory Syncytial Virus, or RSV. For most adults, RSV is like a mild cold, but for babies, especially very young ones, it can cause more serious breathing problems. This study wants to find out exactly how much of a problem RSV is for healthy babies in the UK.

Researchers will follow a large group of healthy babies for several years to see how often they catch RSV, how sick they get, and whether they need to go to the doctor or even hospital. They'll also be looking at the related costs for families and the healthcare system, and how the illness affects a family's daily life and wellbeing. The aim is to get a really clear picture of the full 'burden' of RSV – how widespread it is, its effects on children's health, and the impact on families.

This information is vital because it helps doctors and public health experts understand who is most at risk and how best to prevent and treat RSV. By identifying risk factors, they might be able to develop better strategies to protect babies from this common virus. The study won't test new medicines, but will gather important information to improve future care.

Key takeaways

This study aims to understand how RSV affects healthy babies in the UK.
It will follow babies for several years to track RSV infections and their impact.
Information gathered will help improve future prevention and care for RSV.
Participation involves either questionnaires or more detailed check-ups and samples.
No new treatments are being tested; it's an observational study.
You can withdraw your baby at any time without affecting their medical care.

Who may be eligible?

This study is looking for healthy babies who were born full-term, meaning at least 37 weeks gestation. They need to be born at one of the hospitals taking part in the study. Importantly, the birth mother needs to give her informed consent for her baby to participate.

Unfortunately, babies cannot join if they have serious existing health problems like major heart, lung, genetic, or immune system conditions, or if they were born prematurely (before 37 weeks). Babies who are very unwell at the time of recruitment, for example with a serious infection, also can't take part. It's also important that parents can understand and communicate in the local language, and live within an accessible distance of the study sites.

Finally, if the mother received an RSV vaccination during her pregnancy, the baby would not be eligible for this study, as this might affect the baby's natural response to RSV.

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.

Was your baby born full-term (at least 37 weeks)?
Is your baby generally healthy and does not have any serious long-term medical conditions?
Can you understand and communicate in the local language?
Were you NOT vaccinated against RSV during your pregnancy?
Do you live within a reasonable distance of one of the participating study hospitals?

Answer every question to see your result.

What does participation involve?

If your baby takes part, there are two main ways to be involved. Most babies (around 1800) will be in the 'passive' group. For them, we'll collect some basic information when they join, and you'll complete a questionnaire about their health when they turn one. If your baby happens to be admitted to hospital with a breathing illness, the study team might ask for your permission to follow their health until they are 3 or 6 years old.

A smaller group of babies (around 200) will be in the 'active' group. For these babies, we'll collect more detailed information and samples, including blood, nose swabs, urine, and stool, when they first join. During their first winter (October to May), you'll have weekly phone calls with the study team to check for any breathing symptoms. If your baby shows signs of RSV (confirmed by a quick test), further samples will be collected at that time and again about seven weeks later. Babies in this group will also be followed up for up to 3 or 6 years with additional consent. You'll always be able to discuss and understand what's involved before agreeing to any part of the study.

Potential risks and benefits

Taking part in this study won't directly benefit your baby's health immediately, as it's an observational study that doesn't test new treatments. However, the information gathered will be incredibly valuable to help us understand RSV better and improve care for babies in the future. For babies in the 'active' group, there are some minor potential risks from collecting samples, such as a brief discomfort from a blood test or a nose swab. The study team will always ensure your baby's comfort and safety. You are completely free to withdraw your baby from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

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

University of Oxford
Verified postcode
Oxford, United Kingdom

Common questions

What is RSV?

RSV is a common virus that causes cold-like symptoms, but in babies, it can sometimes lead to more serious breathing problems like bronchiolitis.

Will my baby get any special treatment in this study?

No, this study is about observing and understanding RSV, not testing treatments. Your baby will receive the usual medical care if they get sick.

How long will my baby be in the study?

Depending on which group your baby is in, and with your consent, they could be followed for up to 3 or 6 years.

Is my baby's personal information kept private?

Yes, all personal information collected in the study will be kept strictly confidential and anonymous to protect your baby's privacy.

What if I change my mind about my baby participating?

You are free to withdraw your baby from the study at any time, for any reason, without it affecting their medical care.