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Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry in Children and Adolescents
RECRUITINGSponsored by University Children's Hospital Basel
Actively Recruiting
SponsorUniversity Children's Hospital Basel
Started2020-09-11
Est. completion2030-07
Eligibility
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04461821
Summary
This study is to investigate breath analysis (breath metabolomics) combined with established bioinformatic tools as a platform for companion diagnostics.
Eligibility
Healthy volunteers accepted
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 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 T1D population: * Known malignancy, active smoker (passive smoke exposure is not an exclusion criterium), relevant congenital defects.
Conditions4
DiabetesNeurological DisordersRespiratory DiseasesType 1 Diabetes
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Actively Recruiting
SponsorUniversity Children's Hospital Basel
Started2020-09-11
Est. completion2030-07
Eligibility
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04461821