Actively Recruiting

Age: 1Year - 5Years
All Genders
NCT06237660

Longitudinal Preschool Wheeze Biomarker Study

Led by Imperial College London · Updated on 2024-04-29

150

Participants Needed

1

Research Sites

134 weeks

Total Duration

On this page

Sponsors

I

Imperial College London

Lead Sponsor

A

Action Medical Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

Preschool children (aged 1-5 years) account for 75% of all UK childhood wheezing hospitalisations. This has not changed over 20 years, meaning current treatments are not working and a new approach is needed. Currently, all preschool wheezers are treated with inhaled steroids. However, only about 25% of patients, with allergies, respond well to inhaled steroids; for the other 75%, they are ineffective. This research group has found that some preschool wheezers may have other causes but there are no specific, non-invasive tests to match the right treatment to each child. The goal of this observational study is to test various bedside tests for this purpose in preschool children with wheeze, to see if they are feasible, accurate and acceptable in this age group. The research team would like to investigate the following aims: Aim 1 - To test the proposed panel of simple bedside tests below, to see how accurately they corelate with lower airway infection or inflammation. Aim 2 - To test the acceptability of these bedside tests are to parents and children, and if they reflect the child's symptoms, symptoms control and medication use. Aim 3- A small proof-of -concept study, to test if these simple bedside tests, can be used to determine treatment for each individual child. The panel of simple non-invasive tests that the research team are proposing are: 1. Skin prick tests to common allergies (house dust mite, cat, dog, grass, tree pollen, mixed moulds) 2. Finger prick blood test 3. Phlegm test for bacteria 4. Nose and throat swab for bacteria 5. Lung function test called forced oscillation technique (FOT)

CONDITIONS

Official Title

Longitudinal Preschool Wheeze Biomarker Study

Who Can Participate

Age: 1Year - 5Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 1 to 5 years
  • More than 2 hospitalizations for acute wheeze in the last year, or
  • At least 1 admission requiring high dependency unit or intravenous bronchodilator therapy in the last year
  • Children undergoing bronchoscopy as part of their standard medical care (Aim 1 only)
Not Eligible

You will not qualify if you...

  • Alternative respiratory diagnosis such as cystic fibrosis or bronchiectasis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Royal Brompton Hospital

London, United Kingdom, SW3 6NP

Actively Recruiting

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Research Team

C

Cheuk Fung Wong

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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