Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry in Children and … (NCT04461821) | Clinical Trial Compass
RecruitingNot Applicable
Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry in Children and Adolescents
Switzerland3,600 participantsStarted 2020-09-11
Plain-language summary
This study is to investigate breath analysis (breath metabolomics) combined with established bioinformatic tools as a platform for companion diagnostics.
Who can participate
Age range22 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* Physical or intellectual impairment precluding protocol adherence.
Additional exclusion criteria for respiratory disease population:
* Known malignancy, active smoker (passive smoke exposure is not an exclusion criterium), known inflammatory diseases (e.g. autoimmune disease) that require medical and/or pharmacological treatment and is associated with an inflammatory response, relevant congenital defects
Additional exclusion criteria for neurological disease population:
* Known malign…
What they're measuring
1
Days of hospitalization
Timeframe: approx 30 days (from beginn hospitalisation to discharge date)
2
Change in Mass spectrometric profile of exhaled breath patterns
Timeframe: Week 0 (first regular clinic visit) to Follow-up visits (approx. years 1-10)
3
Change in Concentration of exhaled metabolites of pharmacotherapy
Timeframe: Week 0 (first regular clinic visit) to Follow-up visits (approx. years 1-10)