Feasibility randomised controlled trial of a novel postural management night-time intervention to improve respiratory health of children with complex neurodisability (ADAPT)

Research question Is it feasible to conduct a randomised controlled trial of a novel night-time postural intervention at home for children and young people with complex neurodisability (CYPCN) at risk of aspiration pneumonias? Background CYPCN are at increased risk of recurrent chest infections and chronic respiratory illness.

For those with more severe neurodisability, respiratory illness is the leading cause of morbidity and mortality, and the commonest cause for hospitalisation.

Aspiration is a major cause of respiratory illness in CYPCN, and its risk increases at night when they are unattended in a lying position.

Much attention has been paid to the effects of posture at night on deformity; little research into the impact of night-time positioning on CYPCN s respiratory health or secretion management.

Breathe-Easy is a novel night-time postural intervention which aims to reduce saliva and gastric contents aspiration into the lungs through semi-prone positioning, by allowing gravity drainage from the upper airway. It has shown promising results and good acceptability in a small proof-of-concept study.

Aims 1.

To evaluate the feasibility of delivering the Breathe-Easy intervention safely in four geographically varied community NHS settings. 2.

To provide information necessary to design a definitive randomised controlled trial to test the clinical and cost effectiveness of Breathe-Easy.

Methods We will recruit 50 CYPCN from four sites meeting the following inclusion criteria: dependent upon others to position/move their bodies, equivalent to GMFCS IV-V. high risk of aspiration linked to swallowing difficulties, equivalent to EDACS IV-V. aged 2-18-years. fed via gastrostomy/jejunostomy. at least one lower respiratory tract infection requiring antibiotics in past 12 months.

Participants will be randomised to a 6-month trial of Breathe-Easy or usual care. We will collect data on children s respiratory health, sleep and quality of life at baseline, three and six months.

We will conduct a process evaluation examining the feasibility of recruitment, intervention delivery, quality of implementation, data collection tools, acceptability to stakeholders, safety and contextual factors.

We will assess the feasibility of progression to a definitive trial, including setting trial parameters and health economic analysis.

Candidate primary outcome measures selected are: reduced antibiotic usage for chest infections. reduced hospitalisation days due to chest infections. Timelines for delivery Two-year study November 2024 to October 2026. Regulatory approvals by month 3. Recruited participants by month 15. Data collection completed by month 21.

Data analysis and report by month 24.

Anticipated Impact and Dissemination As a feasibility study, the main impact will be to determine whether a full RCT is feasible, and to provide data to plan a successful RCT.

The criteria for progression to full RCT are a recruitment rate of >1 per site per month, >70% completion, compliance and acceptability rates, and suitability of one or both candidate primary outcomes.

We will present and publish our protocol and findings and in national and international meetings and peer reviewed journals as well as disseminating to families, aiming to create interest and involvement to swiftly progress to a full RCT.