Longitudinal Preschool Wheeze Biomarker Study

RecruitingOBSERVATIONAL
Enrollment

150

Participants

Timeline

Start Date

February 1, 2024

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2026

Conditions
Wheezing
Interventions
PROCEDURE

Bronchoscopy, with bronchoalveolar lavage and endobronchial biopsy

These children who will be having a bronchoscopy (a long thin tube, with a camera at the end, which is put inside the lung to look at and collect samples) as part of their standard clinical management, determined by their own consultants or treating physicians. They will be having lung samples (washings from the lung and a tiny piece of tissue taken from the breathing tubes) taken as part of their usual medical management. The research team will ask for consent to use the leftover samples for the bronchoscopy, for the study

DIAGNOSTIC_TEST

Skin prick test

To identify children with allergies. This test will not be done if the child has had allergy testing in the last 6 months

DIAGNOSTIC_TEST

Finger prick blood test

Finger prick testing will be used for blood samples, and it is the same technique used by children with diabetes, to test their blood sugar levels, and therefore is regularly used in this age group successfully. The research team will be obtain the results within minutes, using a point-of-care device. A few more drops of blood, from the same finger prick sample, will be taken to look at how one of the blood cells work, in more detail, in the laboratory. There is no additional finger prick required for this lab test, and the drops of blood will be collected at the same time, from the same prick, as the point of care test.

DIAGNOSTIC_TEST

Forced oscillation technique (FOT)

Breathing test will be performed using forced oscillation technique (FOT), to see how the child's lungs work and to detect airway inflammation. The test will be explained to the child and completed using our established protocols. This test will only require the child to breathe in and out normally, and therefore can be done in preschool aged children. The current test that is used to check lung function called spirometry cannot be used in preschool children, as it involves following complicated instructions. The aim is to assess how well this newer lung function test is tolerated, in children aged 1-5 years.

PROCEDURE

Sputum induction

Sputum induction is a test of obtaining phlegm after inhalation of salt water mist (saline nebuliser) and this will allow the research team to look for any relationships between infection in the lungs and the accuracy of the less invasive, nose and throat swabs. The research team will obtain phlegm samples, with a quick suction after patients have inhaled the salty mist (saline nebuliser) which will help loosen up their phlegm. If the child can cough it up, they will be encouraged to do it.

DIAGNOSTIC_TEST

Oropharyngeal swab

Swabs from children's nose and throats (similar to swab tests that are done for Covid tests), that will be used to test for bacterial infection

Trial Locations (1)

SW3 6NP

RECRUITING

Royal Brompton Hospital, London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Action Medical Research

OTHER

collaborator

Masonic Charitable Foundation

UNKNOWN

collaborator

Royal Brompton & Harefield NHS Foundation Trust

OTHER

lead

Imperial College London

OTHER

NCT06237660 - Longitudinal Preschool Wheeze Biomarker Study | Biotech Hunter | Biotech Hunter