None listed
Conditions
Brief 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).
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
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.
Sponsors
Queensland University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Months to 6 Years
Healthy volunteers
No
Inclusion criteria
Children (aged 0.5 to 6 years) with recurrent wheeze (2 or more reported wheeze episodes) and/or suspected asthma (e.g. chronic (>4 weeks) cough with recurrent exertional breathlessness).
Exclusion criteria
(a) suspected chronic suppurative lung disease e.g. chronic wet cough, (b) daily maintenance inhaled corticosteroids (ICS) prescribed by a paediatric respiratory specialist, (c) previously enrolled, (d) conditions that also cause wheeze (e.g. cystic fibrosis, tracheomalacia or (e) unable to complete patient reported outcomes (PROs)
Outcome results
None listed