TY - JOUR
T1 - Can RESPiratory hospital Admissions in children with cerebral palsy be reduced?
T2 - A feasibility randomised Controlled Trial pilot study protocol (RESP-ACT)
AU - Marpole, Rachael
AU - Blackmore, A. Marie
AU - Wilson, Andrew C.
AU - Cooper, Monica S.
AU - Depiazzi, Julie
AU - Langdon, Katherine
AU - Moshovis, Lisa
AU - Geelhoed, Elizabeth
AU - Bowen, Asha
AU - Gibson, Noula
N1 - Funding Information:
This work was supported by Research Translation Projects (grant number: RTP2019), the Government of Western Australia (grant number: NA) and Cerebral Palsy Alliance (grant number: PHD00221).
Publisher Copyright:
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2024/2/15
Y1 - 2024/2/15
N2 - 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).
AB - 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).
KW - chronic airways disease
KW - developmental neurology & neurodisability
KW - paediatric thoracic medicine
KW - randomized controlled trial
UR - http://www.scopus.com/inward/record.url?scp=85185288155&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2023-076730
DO - 10.1136/bmjopen-2023-076730
M3 - Article
C2 - 38365293
AN - SCOPUS:85185288155
SN - 2044-6055
VL - 14
SP - 1
EP - 8
JO - BMJ Open
JF - BMJ Open
IS - 2
M1 - e076730
ER -
