Understanding RSV: Severe Disease and the Long Term Consequences
This research is all about Respiratory Syncytial Virus (RSV), a common cold-like illness that can make young babies very unwell. We want to understand why some babies develop severe RSV and if having RSV as a baby can lead to problems like wheezing or asthma later in childhood. We're studying two groups of babies under 12 months old: those with RSV infection and healthy babies without RSV. We'll collect samples and follow them for up to six years using questionnaires. This will help us learn more about severe RSV, how to manage it, and potentially find ways to identify babies at risk, ultimately aiming to improve care and reduce the long-term impact on children's health.
At a glance
What is this study about?
This study is called 'Understanding RSV: Severe Disease and the Long Term Consequences'. It's all about a common illness called Respiratory Syncytial Virus, or RSV for short. RSV often feels like a cold in adults, but for very young babies, older people, or those with other health problems, it can cause severe breathing difficulties.
Globally, RSV affects millions of young children every year, leading to many hospital visits. Importantly, we know that having RSV as a baby can sometimes be linked to problems like wheezing and asthma later on. This research aims to understand why some babies get very sick with RSV and others don't, and to explore these long-term effects. By understanding this better, doctors hope to improve how they care for babies with RSV and potentially find ways to prevent serious illness or its long-term impact.
We are looking for around 275 babies under one year old who have RSV and are in hospital, and a smaller group of 40 healthy babies who don't have RSV. By comparing these groups, we hope to discover important information about RSV infection and its effects on children's health over time. Your participation could help improve future care for babies with this common virus.
Key takeaways
- This study investigates RSV in babies under 12 months.
- It aims to understand why RSV can be severe and if it has long-term effects.
- Participation involves sample collection and annual questionnaires for up to 6 years.
- The study compares babies with RSV to healthy babies.
- There are no new treatments given; it's purely observational research.
- You can withdraw your baby at any time without impacting their care.
Who may be eligible?
To join the study, your baby must be under 12 months old. You, as their parent or guardian, must be willing and able to understand and sign the consent form, and you need to have a working phone number.
If your baby has RSV and you're interested in joining 'Group 1' (babies with RSV), they must have been in hospital for less than 48 hours when you enrol, or within 96 hours of their illness starting. You also need to live close enough to one of the study centres for a nurse to visit your home about 6-8 weeks later.
Your baby cannot join the study if they have already received treatment for RSV (like a medicine called ribavirin), or if they've had an RSV vaccine or preventative medicine (like palivizumab). Babies who have taken certain other medicines, like oral steroids or montelukast, within 7 days of enrolling, also cannot participate.
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 less than 12 months old?
- Are you able to provide consent for your baby and do you have a phone?
- If your baby has RSV, were they in hospital for less than 48 hours when you think of joining, or within 96 hours of their illness starting?
- If your baby has RSV, do you live close enough for a home visit in 6-8 weeks?
- Has your baby NOT received treatment or preventative medicines for RSV, or certain other medications recently?
What does participation involve?
If your baby takes part, there will be some samples collected: a swab from their nose, and samples of blood, urine, and stool (poo). If your baby has RSV, these samples will be taken when they first join and again about 6-8 weeks later, after they've recovered. You'll also be asked to complete a simple online diary for two weeks about your baby's health and your own.
If your baby is in the healthy control group, these samples will only be taken once when they join. A week later, we'll check in with you to see if your baby has become unwell.
Both groups of babies and their families will then be followed up each year by filling out a questionnaire. This will continue for at least one year, and for up to six years in total, depending on when your baby joins the study.
Potential risks and benefits
Locations (2)
- Oxford University Hospitals NHS TrustVerified postcodeOxford, United Kingdom
- Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical MedicineVerified postcodeOxford, United Kingdom
Common questions
What is RSV?
RSV is a common virus that usually causes mild cold-like symptoms, but it can be more serious for babies and young children, sometimes leading to breathing difficulties.
Will my baby get any special treatment in this study?
No, this study is about understanding RSV, not providing special treatment. Your baby will receive the usual standard medical care for their illness.
How often will we need to visit the hospital?
Most follow-up will be done through questionnaires at home, though some initial samples may be taken in hospital or a clinic. For babies with RSV, a nurse will visit your home for the follow-up samples around 6-8 weeks later.
What kind of samples are collected from my baby?
We will collect a nasal swab (from their nose), and small samples of blood, urine, and stool (poo).
What if I change my mind after joining?
You are completely free to withdraw your baby from the study at any point, and this decision will not affect your baby's medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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