Breathe-Easy
Research type
Research Study
Full title
Breathe-Easy: a pilot study to examine the acceptability and feasibility of a novel postural management night-time intervention (PMN-TI) to improve respiratory health of children with complex neuro-disability.
IRAS ID
288217
Contact name
Sarah Crombie
Contact email
Sponsor organisation
Sussex Community NHS Foundation Trust
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Background:
This study concerns children with complex neuro-disability. Damage to the developing brain leads to lifelong disturbances in motor control, seizures, cognition, communication, eating and drinking, and behaviour. Children with complex neuro-disability are dependent upon others to move and position them. Children commonly experience chronic lung disease, leading to frequent hospitalisation, medical interventions and premature death. Respiratory illness may be triggered by “aspiration”, i.e. when saliva, food, liquid or stomach contents enter the lungs. Aspiration risks increase at night-time when supervision is limited and children are positioned on their backs. Some children experience repeated breathing complications requiring prolonged hospital stays including respiratory support in intensive care.
Novel Intervention:
Consultant Respiratory Paediatrician Dr Kapur and Physiotherapist Hilda Perry developed a night-time intervention to optimise gravity-based upper airway drainage, to improve respiratory health of children with complex neuro-disability. The intervention includes safe positioning in three-quarters prone lying with head slightly lowered to allow gravity to drain secretions from mouth.
This challenges usual safe night-time positioning recommendations. Clinical findings support use of intervention with 70%-80% reduction in hospital admissions (n=20).
Aim:
We will examine acceptability and feasibility of this intervention to improve respiratory health of children. We will engage stakeholders in a pilot study, building towards a definitive trial of the intervention’s clinical and cost effectiveness.
Method:
We will recruit 10 children to a prospective Before-After observational study. The team will work with children and families to determine the safest, most comfortable night-time position to achieve essential elements of the intervention.
We will collect data to assess feasibility and acceptability of the intervention including recruitment. We will collect data pre-intervention, at 3 months and after 6 months to assess respiratory symptoms, quality of sleep, use of antibiotics and family experiences. We will interview all participants.
Data will be analysed using descriptive statistics and Thematic Network Analysis.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
20/LO/1239
Date of REC Opinion
17 Dec 2020
REC opinion
Further Information Favourable Opinion