The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

Diagnostic investigations in paediatric respiratory and sleep medicine are often challenging due to patient size (due to prematurity), tolerability, and compliance with gold standard equipment. Children with sensory/behavioural issues, at increased risk of sleep disordered breathing (SDB), often find tolerating standard diagnostic equipment difficult. There is a need to develop non-invasive, wireless, devices designed for the paediatric population. Devices must address health in-equalities as high-risk children, with low birth weights, genetic syndromes, or complex neuro-disabilities, are often unable to undergo current investigations, particularly in sleep medicine. Prompt and accurate diagnosis of SDB is important to facilitate early intervention and improve outcomes Infants in the neonatal period can have immature breathing control which manifests as excessive central breathing pauses, apnoea's, whilst asleep requiring oxygen therapy. There is also a risk to newborn term infants of sudden unexpected neonatal collapse, even in low risk babies. Diagnosis of breathing issues in babies can be challenging since babies are often too small for standard monitoring equipment. Effective monitoring and appropriate treatment of apnoea's has been shown to improve prognosis in terms of 5-year mortality and neurodevelopmental outcomes. Children with epilepsy are at risk of epileptic apnoea during a seizure (ictal) or post-ictal apnoea following an epileptic seizure. Epileptic and post-ictal apnoea have been implicated as causes of sudden unexpected death in epilepsy (SUDEP). Epilepsy affects approx. 50 million people worldwide. The risk of SUDEP varies in different underlying causes of epilepsy but is estimated to be the cause of 1.2 deaths for every 1,000 children with epilepsy each year. This observational study is part of a phased clinical program of research that aims to validate a small wearable biosensor developed by PneumoWave Ltd in a paediatric clinical setting with the overall primary endpoints of monitoring and assessing respiratory pattern as an aid to sleep diagnostics, and as a device to monitor apnoea in neonatal patients and children with epilepsy at risk of SUDEP.

Eligibility
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: 16
Healthy Volunteers: f
View:

⁃ Group 1 - CR-poly group

• Patient undergoing overnight CR-poly

• Age birth to \>=16 years

• Are willing and able to give informed assent/consent or have available next of Kin to provide informed consent on the participant\'s behalf

• Able (in the Investigators opinion) to comply with all study requirements

• Can speak and read English

⁃ Group 2 - Apnoea group

• Inpatient in neonatal unit

• Age birth (from 30 weeks gestational age) to term corrected

• Parents willing and able to give informed consent

• Able (in the Investigators opinion) to comply with all study requirements

• Can speak and read English

⁃ Group 3- VT Group attending epilepsy monitoirng unit

• Inpatient receiving video-telemetry epilepsy monitoring unit

• Age birth to \<16 years

• Parents willing and able to give informed consent

• Able (in the Investigators opinion) and willing to comply with all study requirements

• Can speak and read English

Locations
Other Locations
United Kingdom
Royal Hospital for Children, Glasgow
RECRUITING
Glasgow
Royal Hospital for Children, Glasgow
ACTIVE_NOT_RECRUITING
Glasgow
Contact Information
Primary
Ross J Langley, MBChB BSc PhD MRCPCH
ross.langley@ggc.scot.nhs.uk
01414516582
Backup
Hannah Vennard, MBChB BMSc
hannah.vennard@ggc.scot.nhs.uk
01414516582
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 225
Treatments
Patient attending for overnight cardiorespiratory polysomnography sleep study
Any patient attending the Royal Hospital for Children, Glasgow sleep laboratory for overnight cardiorespiratory polysomnography for evaluation of sleep disordered breathing. Pneumowave device will collect data from patients alongside standard clinical monitoring.
Patients in the neonatal unit, Royal Hospital for Children, Glasgow, at risk of central apnoea
Any patient currently in the Queen Elizabeth University Hospital campus neonatal unit at risk of central apnoea receiving standard care (this may include mechanically ventilated patients). Pneumowave device will collect data from patients alongside standard clinical monitoring.
Patients attending the epilepsy monitoirng unit for Video Telemetry
Any patient attending the Royal Hospital for Children, Glasgow Epilepsy Monitoring Unit for inpatient video-telemetry at risk of apnoea during and following seizures
Sponsors
Leads: NHS Greater Clyde and Glasgow
Collaborators: INNOVATEUK

This content was sourced from clinicaltrials.gov

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