None listed
Conditions
Brief summary
Cerebral palsy (CP) is the commonest physical disability in childhood. Respiratory illness is the leading cause of death for children with CP, and is responsible for more multi-day hospital admissions than any other cause. Children with CP admitted to hospital for respiratory illness stay in hospital, on average, 2.5 times longer than other children, and two in five are re-admitted the following year. At present, there is no coordinated approach to preventing respiratory illness in children with CP. Children with respiratory illness are usually not referred for specialized care until their respiratory illness is advanced and often life-threatening. The BREATHE-CP (Better REspiratory and Airway Treatment and HEalth in Cerebral Palsy) research team have determined the early risk factors for respiratory illness in children with CP so that they can be treated much earlier. We have also systematically reviewed the research literature to determine the most effective treatments for preventing respiratory disease. However, there is very little research evidence. Treatment studies are urgently needed. We have also asked researchers and clinicians worldwide with expertise in respiratory health in CP what treatment approaches they would recommend, and developed a consensus statement for management of respiratory illness in children with CP. This study will trial this recommended approach to management of respiratory illness in children with CP. Treatments will be individualized for children with CP at risk of respiratory illness to find out whether they are feasible, acceptable, and likely to be effective by comparison with current standard treatment. If the trial is successful, we will apply for funding to do a large-scale trial across several hospitals to improve respiratory health and quality of life for children with CP at risk of respiratory illness and reduce healthcare costs.
Interventions
The intervention group will receive a comprehensive respiratory assessment and an individualized action plan. Participants in the intervention group will be offered the interventions outlined in the “Consensus statement for prevention and management of respiratory disease in young people with cerebral palsy: Standards of care.” At the time of preparing this protocol, the consensus statement has not yet been published, and so the interventions will be described in detail here.
Children in the in
The intervention group will receive a comprehensive respiratory assessment and an individualized action plan. Participants in the intervention group will be offered the interventions outlined in the “Consensus statement for prevention and management of respiratory disease in young people with cerebral palsy: Standards of care.” At the time of preparing this protocol, the consensus statement has not yet been published, and so the interventions will be described in detail here. Children in the intervention group will receive an initial assessment that will include physiotherapy, speech pathology, and medical components. This assessment is expected to take a total of 5-6 hours. A physiotherapist will assess: respiratory signs and symptoms; breathing pattern; chest expansion; spinal deformity; chest tone; strength and function of cough; respiratory rate; and blood oxygen. A speech pathologist will use the following assessments: Eating and Drinking Ability Classification System (EDACS) or Dysphagia Outcome Severity Scale (DOSS); oromotor function; videofluoroscopy; and swallowing assessment. A respiratory registrar will do the medical assessment, including: nutritional status; reflux; seizure control; sialorrhea; and constipation/delayed gastric emptying. Within 2 weeks of the assessment, the multidisciplinary treatment team will create an individualized plan for each child in the intervention group based on the results of this assessment. The children in this study will have complex medical issues and risks and so the plan for each child will be unique and complex, and will depend on clinicians’ clinical judgements and families’ preferences for treatments. Therefore, the study protocol cannot prescribe the frequency or intensity of treatment for any particular child. However, the general principles (summarized from the consensus statement) are as follows: • In children who are aspirating: referral to speech pathologist to assess swallowing safety; consideration of modified textures and postural support. • In children with epilepsy: monitoring of seizures and/or referral to epilepsy specialists for management of uncontrolled seizures. • In children with gastro-oesophageal reflux disease: management of reflux. • In children who are drooling: review of medications that may cause drooling if the child is aspirating saliva; consideration of management with oral medications, salivary gland Botulinum Toxin, or salivary gland surgery. • In children with a history of apnoea, snoring or on examination there are large tonsils/swollen turbinates: referral to Ear, Nose and Throat specialists for assessment and management of upper airway obstruction. • In children with asthma: management of asthma and monitoring of the effectiveness of medications. • In children with respiratory illness: antibiotics (using antibiotic guidelines); saliva management; optimization of general health (including assessment of nutritional status, reflux, and risk of aspiration when unwell); dysphagia assessment and management plan to facilitate safe and functional feeding when unwell. • In children with respiratory illness and a productive cough: referral to physiotherapists for airway clearance regimes. • In children with symptoms of airways disease or sputum retention: referral to a respiratory physiotherapist and consideration of suction. • In all children: Physiotherapists educate carers ways to maintain clear airways, identify ineffective cough, consider positioning and regular chest physiotherapy. Optimization of chest wall mobility to prevent restrictive lung disease, including maximizing physical activity and minimizing immobility; managing movement disorders; assessment of kyphosis, kyphoscoliosis, and lordoscoliosis, and use of postural plan; and where surgery for scoliosis is under consideration, a multidisciplinary team will evaluate risks and benefits. Assessment and optimization of nutrition. Optimization of respiratory function, physical activity, and fitness. Regular dental care. Vaccination against influenza. The intervention will commence within a week of the time when the individualized plan is agreed upon. The intervention group will receive up to one hour of weekly individualized face-to-face physiotherapy and/or speech therapy review and advice for the first 4 weeks. After that, there will be ongoing physiotherapy (up to 1.5 hours/fortnight), speech pathology (up to 1 hour/fortnight), and/or medical (up to ½ hour/fortnight) management according to need from existing clinical staff at the children’s hospital and community-based therapy service. These sessions will continue for up to 12 months (the study period). During the individual sessions, the physiotherapist will provide education regarding the symptoms and signs of a respiratory exacerbation. A nurse will coordinate care and provide individual education and training for suction and ventilation technology where required. Duration, intensity, and location (hospital or home) of the interventions will be individualized. The clinicians administering the interventions will record all assessments and interventions, time taken, and adherence on a standard data collection sheet.
Sponsors
Telethon Kids Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to 12 Years
Healthy volunteers
No
Inclusion criteria
• Cerebral palsy, • 0 to 12 years of age inclusive, and • at risk of respiratory hospitalization, as determined by the respiratory risk checklist developed by our research team from our 5-year prospective cohort design. The respiratory risk checklist is a 19-item tool. It contains questions about the child’s frequency of respiratory symptoms, medical attention for respiratory illnesses in the previous year, method of nutritional intake, and presence of co-morbidities. All questions require only a tick in a box. The checklist is easily completed within 5 minutes. The intervention is for children with CP at risk of at risk of respiratory hospitalizations. During the trial, some data regarding the children will be provided by the parents and clinicians of these children.
Exclusion criteria
• On continuous home oxygen. • On ventilatory support (Continuous Positive Airway Pressure (CPAP)/non-invasive ventilation). • Tracheostomy. • Enrolled in paediatric palliative care programme with restrictions or guidelines about active management other than end-of-life care. • Living outside the metropolitan area. • Family requires a professional translator or interpreter to participate in the trial. • There are concerns that the home environment may not safe for clinicians to conduct the intervention.
Outcome results
None listed