RecruitingACTRN12624000441516

Preschool Outcomes of Wheeze Employing Reliable Ergonomic Digital-technology (POWERED)

A multicentre RCT study to determine whether using a bundle (use of WzS with a management plan) reduces unscheduled doctor visits in preschool aged children with recurrent wheeze

Sponsor

Queensland University of Technology

Enrollment

206 participants

Start Date

Oct 1, 2024

Study Type

Interventional

Conditions

Recurrent wheeze in pre-school children (Preschool Wheeze)

Summary

Preschool children with wheeze (PSW) is very common and has higher morbidity than any other asthma group. PSWs very high unmet needs are documented in international parent/end-user surveys. Although many no longer wheeze by 6y, ~40% have recurrences, require hospitalisation and it is not a benign illness. Yet, identifying wheezing is challenging for parents (>50% disagreement between doctors & parents) and many cultures (incl. Indigenous Australians) do not have a word for wheeze. This may cause under- or over-diagnosis of asthma, & lead to over- or underuse of medications, children undergoing unnecessary procedures & high parental anxiety. Giving all children asthma meds is very poor practice as there are adverse events associated with these meds and it is against parents’ wishes. Our multicentre RCT study addresses the need to manage recurrent PSW by objectively defining wheeze using as a bundle (1) an AI-developed tool (WheezeScan, WzS) and (2) a wheeze management plan. Recruiting children from hospitals and community clinics, we plan to recruit 206 children with recurrent PSW including those from our remote Indigenous clinics to determine if this intervention (WzS with management bundle) reduces unscheduled doctor visits (primary aim), and other clinically important outcomes (hospitalisation, time to next unscheduled doctor visit, quality-of life).

Eligibility

Sex: Both males and femalesMin Age: 6 MonthssMax Age: 6 Yearss

Plain Language Summary

Simplified for easier understanding

The POWERED study, led by Queensland University of Technology, is a large multi-centre trial testing an AI-powered tool called WheezeScan (WzS) to help parents and clinicians accurately identify and manage wheezing in young children. Wheezing in preschool children is very common and is a major cause of hospital visits — but it is often misidentified because parents and doctors sometimes disagree on whether a child is actually wheezing, and some cultures have no word for the sound. The study will combine WheezeScan (which uses a phone microphone to detect wheeze) with a clear management plan, and compare this to standard care in 206 children with recurrent wheeze. The main goal is to reduce unscheduled doctor visits, with secondary aims of reducing hospitalisations and improving quality of life. Your child may be eligible if they are aged 6 months to 6 years and have had 2 or more wheezing episodes or suspected asthma with chronic cough and breathlessness. Children on daily prescribed inhaled steroids from a specialist, with chronic wet cough suggesting infection, or with conditions like cystic fibrosis would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Use of WheezeScan (WzS) with a management plan (called the 'bundle'). WzS is a portable user-friendly digital device that listens to 30sec of breathing then objectively documents wheeze using AI-informed signal processing. WzS is manufactured by Omron (Japan). Parents will be trained by the research nurses/assistants using a standard protocol provided by the manufacturers (sse link https://www.omron-healthcare.co.uk/nebulisers/wheezescan.html). Training occcurs face-to-face and takes between 5 to 15 minutes where the parents are shown how to use the WheezeScan and then does them with the researcher watching. The video on how to use a Wheezescan is also available https://www.youtube.com/watch?app=desktop&v=DnZh-p0ZgP4 Parents are also given a cheat sheet on how to use the Wheezescan and how to complete the e-diary. Adherence will be monitored using participant diaries recorded on-line. Wheezescan will be used at least once a day over the study period of 12 months. The management plan consists of an asthma management plan with the use of inhaled corticosteroids if there is wheeze that is reversed by using salbutamol (400 ugm via space +/-mask). The use of recommended inhaled corticosteroids (fluticasone propionate (250 micrograms) metered dose inhaler, at 2 puffs twice a day) will be intermittent at the onset of a viral infection and/or wheeze for a maximum of 10 days for each episode.

Locations(7)

Queensland Children's Hospital - South Brisbane

NSW,NT,QLD,WA,VIC, Australia

Gold Coast University Hospital - Southport

NSW,NT,QLD,WA,VIC, Australia

The Children's Hospital at Westmead - Westmead

NSW,NT,QLD,WA,VIC, Australia

Royal Darwin Hospital - Tiwi

NSW,NT,QLD,WA,VIC, Australia

The Royal Childrens Hospital - Parkville

NSW,NT,QLD,WA,VIC, Australia

Perth Children's Hospital - Nedlands

NSW,NT,QLD,WA,VIC, Australia

Johor and Selangor, Malaysia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12624000441516