Neurological and respiratory, other diseases of the respiratory system, other disorders of the nervous system Nervous System Diseases
Conditions
Interventions
The research physiotherapist employed at the local NHS site will collect baseline data about the CYPCN from the parents/guardians including medical history and current orthopaedic concerns, medication
Sponsors
Sussex Community NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Inclusion criteria
Inclusion criteria: Children will be invited to participate in the RCT if they meet the following criteria: 1. Dependent upon others to position/move their bodies (Gross Motor Function Classification System IV/V or equivalent) 2. High risk of aspiration linked to swallowing difficulties (Eating and Drinking Classification System IV/V) 3. Aged 2-18 years 4. Fed via gastrostomy/jejunostomy 5. At least one lower respiratory tract infection requiring antibiotics in past 12 months For the surveys, stakeholders will be invited to participate if they are: 1. Parents of children in the RCT 2. Children in the intervention group 3. Healthcare professionals who have been involved in the RCT
Exclusion criteria
Exclusion criteria: 1. CYPCN using naso-gastric tube 2. CYPCN with overnight feeding via gastrostomy that cannot be altered to daytime only (jejunostomy feeds can continue overnight so considered safe) 3. CYPCN transitioning to adult care within trial period 4. CYPCN with planned orthopaedic surgery during trial period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary feasibility outcome measures: 1.1. Recruitment: Proportion of recruited children amongst eligible patients and reasons for not participating; measured using counts from screening and eligibility forms and logs at enrolment. 1.2. Retention: Proportion of participants that completed the feasibility trial out of the number randomised; measured using counts from the validated database records at the end of study (6-months). 2.Proportion of data collection complete per participant (candidate primary outcomes); measured using counts from the validated database records at the end of study (6-months). 3.Standard deviation of the candidate primary outcomes; estimated from the validated database records at the end of study (6-months). 4.Proposed design, sample size and number of centres for a definitive study; agreed at the end of study on discussion with joint TSC/DMEC. 5.1. Acceptability of intervention for participants: Number of nights in position for minimum of 4 hours measured from participant case records at the end of study (6-months). 5.2. Acceptability of intervention for families and healthcare staff: Acceptability measure from surveys of parents and HC professionals at the end of study (6-months). Candidate primary outcome measures evaluated as part of primary feasibility outcome measures #2 and #3 above: 1.Proportion of CYPCN with ‘chest infection’ according to protocol definition amongst eligible patients at 6-months. 2.Time to first ‘chest infection’ from randomisation according to protocol definition. 3.Total time attending hospital in days. 4.Respiratory Health measured using the Bespoke Respiratory Symptom Questionnaire (BRSQ); at baseline, 3 and 6-months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Candidate secondary outcome measures 1. Sleep behaviour measured using a validated questionnaire (CSHQ Abbreviated); at baseline, 3 and 6-months. 2. Health related quality of life of children measured using a paediatric generic preference-based measure instrument (CHU9D); at baseline, 3 and 6-months. 3. Health related quality of life of parents/guardians measured using a generic health related quality of life instrument (EuroQol - EQ-5D-5L); at baseline, 3 and 6-months. 4. Pain or discomfort of participating children measured using the Face Legs Activity Cry and Consolability (rFLACC) scale; at baseline, 3 and 6-months. 5. At the Sussex site only, sleep disordered breathing assessed at home using a portable respiratory polysomnography device (SOMNOtouchTM); at baseline and 3-months. Secondary outcome measures for the process evaluation of the intervention 1. Talking Mats interview with children at 6-months. 2. Survey of parents/carers including trial factors experiences. After completion of participation: after consent, withdrawal from participation or end of study (6-months). 3. Discussion with families who decline intervention. Discussion takes place when families are approached to participate, after consent is declined. 4. Survey of Health Care Professionals at the end of study (6-months). | — |
Countries
England, United Kingdom
Outcome results
None listed