RecruitingNAINTERVENTIONAL

PREcision Medicine Directed Corticosteroids In Children With preSchool Wheeze

This study focuses on young children (aged 2 to 5 years old) who come to the hospital with wheezing, often caused by a virus. Doctors sometimes use oral steroid medicines to help, but they can have side effects, and it's not always clear which children will benefit most from them. This study will use new, fast virus tests that give results in about 30 minutes. The idea is to see if knowing which virus is causing the wheeze can help doctors make better decisions about giving oral steroids. This first study is a small, pilot project to prepare for a larger study in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Queen's University, Belfast

Enrolment target

120

Start

04 Nov 2024

Estimated completion

03 Dec 2025

Wheezing

What is this study about?

When young children get wheezy, especially after a cold, it can be quite worrying for parents, and they often end up in the emergency department. Wheezing usually happens because a virus has irritated their airways, making them narrower. Doctors often give inhaled medicines, but sometimes they also consider giving oral steroids, which are medicines taken by mouth, to help reduce swelling in the lungs.

The tricky part is that while oral steroids can be helpful for some children, they can also have side effects. Doctors don't always know for sure which children will benefit most from these steroids and which ones might get better without them. This means some children might get steroids they don't really need, and others might miss out on a treatment that could help them.

This study will try to find a better way to make these decisions. New, quick tests can now identify viruses in about half an hour. Researchers wonder if knowing which virus is causing the wheeze can help predict whether a child will respond well to oral steroids. This first small study will help them figure out if using these quick tests in an emergency department setting is practical, to pave the way for a bigger study later on.

Key takeaways

This study is about young children (2-5 years old) with wheezing.
It aims to see if quick virus tests can help doctors decide on steroid treatment.
The goal is to personalize treatment and avoid unnecessary medication.
It's a small, initial study to prepare for a larger one.
Your child will still receive all standard hospital care.

Who may be eligible?

This study is looking for young children between the ages of 2 and 5 years old. To be included, your child must be coming to the emergency department because they are wheezing.

However, there are reasons why a child might not be able to join. For example, if your child's wheezing is very severe or life-threatening. Children who have other serious health problems, like a very weak immune system, or if they have had severe asthma attacks or been in intensive care for wheezing before, will not be able to take part. Also, if your child was born very prematurely, or has conditions that mean they cannot take oral steroids, they would not be suitable for 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 child aged between 2 and 5 years old?
Is your child currently in the emergency department because they are wheezing?
Is your child's wheezing not considered very severe or life-threatening?
Does your child not have a very weak immune system or very serious health problems?
Has your child not been in intensive care for wheezing before?

Answer every question to see your result.

What does participation involve?

If you decide your child can take part, the first step is for a researcher to discuss the study with you, answer your questions, and get your written permission. Then, a quick swab will be taken from your child's nose to test for common viruses. This test will help decide if your child receives oral steroids or not, with half the children getting them and half not, based on the test result.

During the study, your child will continue to receive all the usual care and treatments recommended by the hospital for wheezing. The study won't change this standard care. The main difference is the quick virus test and then whether oral steroids are offered, based on the test result and a random decision process.

Potential risks and benefits

Taking part in this study could help doctors understand more about wheezing in young children and how best to treat it in the future, which could benefit many children. While oral steroids can have side effects, they are generally safe when used correctly, and the decision on whether to give them will be carefully considered. You are free to withdraw your child from the study at any time, for any reason, without it affecting your child's medical care.

Locations (1)

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

Royal Belfast Hospital for Sick Children
Verified postcode
Belfast, United Kingdom· Recruiting

Common questions

What is 'wheezing'?

Wheezing is a high-pitched whistling sound made when breathing out. It happens when the airways in the lungs become narrow or blocked.

What are oral steroids?

Oral steroids are medicines taken by mouth that can reduce swelling and irritation in the body, including the lungs. They are different from steroids used by athletes.

Will my child's medical care change if we join?

No, your child will still receive all the standard care and treatments the hospital provides for wheezing. The study simply looks at how quick virus tests might help guide the use of oral steroids.

What is a 'feasibility study'?

A feasibility study is a small trial done to see if an idea or method can actually work and is practical before a much larger study is carried out.

How long does the study last?

This study focuses on the initial visit to the emergency department, including the virus test and decision about steroid treatment. It doesn't involve long-term follow-up for the study itself.

How to find out more

Hannah R Norman-Bruce, MBBS

hnormanbruce01@qub.ac.uk (+44) 028 9097 1643 Official trial record

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