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Can RESPiratory hospital Admissions in children with cerebral palsy be reduced? A feasibility randomised Controlled
Rachael Marpole1,2, A Marie Blackmore3,4, Andrew C Wilson5,6
1Respiratory and Sleep Medicine, Perth Children's Hospital, Nedlands, Western Australia, Australia rachael.marpole@research.uwa.edu.au.
Insights
This study tests a new respiratory intervention for children with cerebral palsy (CP). The feasibility trial will assess if the intervention is acceptable, practical, and potentially effective in improving health outcomes for children with CP.
Area of Science:
- Pediatric Pulmonology
- Clinical Trials
- Rehabilitation Medicine
Background:
- Respiratory disease is a leading cause of illness and death in children with severe cerebral palsy (CP).
- Previous research identified risk factors and management strategies for respiratory disease in CP.
- The effectiveness and feasibility of implementing these strategies remain uninvestigated.
Purpose of the Study:
- To conduct a mixed-method feasibility pilot randomized controlled trial to evaluate a novel intervention for respiratory disease in children with CP.
- To assess the acceptability, implementation, practicality, and potential efficacy of the intervention.
- To inform the design of a definitive trial to test intervention effectiveness.
Main Methods:
- A pilot randomized controlled trial involving 20 children with CP (aged 0-12 years) at risk of respiratory disease.
- Intervention group receives comprehensive assessments and an individualized treatment plan; control group receives usual care.
- Data collection includes patient-reported outcomes, qualitative interviews, and health service use for 1 year.
Main Results:
- Feasibility will be assessed by recruitment, retention, and adherence rates.
- Acceptability will be evaluated through qualitative interviews with participants and families.
- Preliminary efficacy will be explored through quality-of-life surveys and changes in health service utilization.
Conclusions:
- This feasibility study will provide crucial data on the implementation and potential benefits of a new respiratory intervention for children with CP.
- Findings will guide the development of a definitive randomized controlled trial protocol.
- Successful implementation could lead to improved respiratory health outcomes and reduced morbidity in this vulnerable population.
Introduction:
The most common cause of morbidity and mortality in children with severe cerebral palsy (CP) is respiratory disease. BREATHE-CP (Better REspiratory and Airway Treatment and HEalth in Cerebral Palsy) is a multidisciplinary research team who have conducted research on the risk factors associated with CP respiratory disease, a systematic review on management and a Delphi study on the development of a consensus for the prevention and management of respiratory disease in CP. These strategies have not been investigated; therefore, it is not known if implementation is feasible, if they improve patient outcomes or if they are acceptable for families.
Methods And Analysis:
Mixed-method feasibility pilot randomised controlled trial with economic analysis. Twenty children with CP aged 0-12 years who are at risk of respiratory disease will be followed up for 1 year. All children will receive baseline assessments for comparison. The control group will receive usual care from their treating teams. The intervention group will receive comprehensive assessments from physiotherapy, speech pathology and respiratory medicine. An individualised investigation and treatment plan will then be made. Participants in both groups will complete fortnightly patient-reported outcome surveys to assess symptoms and health service use. Analysis will include assessments of acceptability through qualitative interviews, implementation by ability to recruit, randomise and retain, practicality including costs of intervention and hospitalisation, and explore efficacy through quality-of-life surveys and decreased health service use for respiratory-related symptoms.
Ethics And Dissemination:
Ethics and governance approvals have been obtained through Child and Adolescent Health Service Human Research Ethics Committee. At completion, this study will lead to the design of the definitive protocol to test intervention efficacy that maximises recruitment, retention and adherence to interventions.
Trial Registration Number:
Australian New Zealand Clinical Trials Registry (ACTRN12620000114943).
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