NCT04461821 Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry in Children and Adolescents
| NCT ID | NCT04461821 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Children's Hospital Basel |
| Condition | Respiratory Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,600 participants |
| Start Date | 2020-09-11 |
| Primary Completion | 2030-07 |
Trial Parameters
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Brief Summary
This study is to investigate breath analysis (breath metabolomics) combined with established bioinformatic tools as a platform for companion diagnostics.
Eligibility Criteria
Inclusion Criteria: * Age 0 ≤ 22 years at study entry and signed informed consent Additional inclusion criteria for respiratory disease population: * Acute disease: - Acute signs for a respiratory disease, indicated by e.g. increased work of breathing (e.g. dyspnea, increased respiratory rate), cough or wheezing. * Chronic disease: - Suspected or confirmed chronic airway disease (e.g. asthma). Additional inclusion criteria for neurological disease population: * Acute disease: - Acute presentation or report within 24 hours of any signs of neurological deficit (motor function, sensoneural, or verbal). * Chronic disease: - Confirmed chronic neurologic disease (e.g. childhood epilepsy). Additional inclusion criteria for T1D disease population: * Acute disease: - Hyperglycemia and/or pH (venous) \<7.3, bicarbonate \>10 mmol/L, increased levels of acetone in blood or urine in the context of newly diagnosed or known T1D. * Chronic disease: - Confirmed diagnosis of T1D Exclusion Criteria: * Ph