Status:
RECRUITING
Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry in Children and Adolescents
Lead Sponsor:
University Children's Hospital Basel
Collaborating Sponsors:
Swiss National Science Foundation
Fondation Botnar (Switzerland)
Conditions:
Respiratory Diseases
Neurological Disorders
Eligibility:
All Genders
Up to 22 years
Brief Summary
This study is to investigate breath analysis (breath metabolomics) combined with established bioinformatic tools as a platform for companion diagnostics.
Detailed Description
Therapeutic drug monitoring (TDM) is defined as measuring concentrations of a drug at one or more time points in a biological matrix after a dose. The purpose of TDM is to individualize the drug dose ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 11 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2030
Estimated Enrollment :
3600 Patients enrolled
Trial Details
Trial ID
NCT04461821
Start Date
September 11 2020
End Date
July 1 2030
Last Update
February 21 2025
Active Locations (1)
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1
University Children's Hospital Basel (UKBB)
Basel, Switzerland, 4031