A feasibility randomised controlled trial of a novel postural management night-time intervention (Breathe-Easy) to improve respiratory health of children with complex neurodisability
Trial acronym: ADAPT
Description
Children and young people with complex neurological conditions often experience recurrent chest infections. These distressing and burdensome illnesses require frequent hospital stays and are the leading cause of premature death.
A major cause of respiratory illness in such children is aspiration, when saliva, food, liquid or stomach contents enter the lungs. Current recommendations advise that children are positioned on their back at night to help with managing posture or reflux, but this position, with reduced supervision at night, increases risk of aspiration.
Our new approach, Breathe-Easy, involves lying children partway onto their fronts to drain secretions from the mouth, and using existing feeding tubes to drain stomach contents overnight.
Aims:
To investigate if:
- Breathe-Easy can be implemented by parents at home, the guidance is clear, the intervention is safe
- recruitment is possible to a trial where participants receive either Breathe-Easy or usual care
- selected measures of health and well-being are appropriate and acceptable for use in a subsequent, larger trial.
Plan:
We will work closely with 50 children and their families in four NHS Trusts to test this new night-time intervention. Children and young people will be able to take part if they:
- depend upon others to position and move their body
- have swallowing difficulties with high risk of aspiration
- are 2-18 years old
- use long-term feeding tubes placed surgically in their stomachs
- have had a chest infection in the last 12 months.
Participants will be randomly allocated for 6 months to Breathe-Easy or usual night-time positioning.
We will collect data at the start of the study, at 3 months and 6 months, including:
Parents’ observations about children’s respiratory health and sleep using questionnaires.Use of antibiotics, X-rays and hospital admissions to treat chest infections from GP and hospital records.
We will ask children and young people, parents, carers and healthcare staff about their experiences of using Breathe-Easy through surveys.
Study design: Feasibility randomised controlled trial
Disease area: Paediatrics
Trial status: Recruiting
Chief Investigators: Dr Sarah Crombie, Dr Akshat Kapur
Sponsor: Sussex Community NHS Foundation Trust (SCFT)
Funder: NIHR RfPB
Start date: 01/01/2025
End date: 31/12/2026
Recruitment target: 50
For further information contact:
E: CTU-ADAPT@bsms.ac.uk