The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study
Status: Not yet recruiting

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.

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.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Group 1 - CR-poly group  Patient undergoing overnight CR-poly Age birth to &amp;gt;=16 years Are willing and able to give informed assent/consent or have available next of Kin to provide informed consent on the participant&amp;#39;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  Exclusion Criteria:  Group 1 - CR-poly group  Unable to provide consent and no next of kin to provide consent on participants behalf Treating clinician deems patient inappropriate to be included in study  Group 2 - Apnoea group  No next of kin to provide consent on participants behalf Treating clinician deems patient inappropriate to be included in study - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Minute - MaximumAge: 16 Years - StdAgeList: Child - StudyPopulation: The target number of participants in this study is 150. 75 patients who fit group 1 characteristics, 75 patients who fit group 2 characteristics. All patients who fit the below criteria will be potential candidates for the study. The study team will confirm their eligibility and then they will be included. - SamplingMethod: Non-Probability Sample