Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry in Children and Adolescents

Recruiting now

Conditions studied: Respiratory Diseases, Neurological Disorders, Type 1 Diabetes

In brief

This study is to investigate breath analysis (breath metabolomics) combined with established bioinformatic tools as a platform for companion diagnostics.

Key facts

Study ID

NCT04461821

Run by

University Children's Hospital Basel

People needed

3600

Starts

2020-09-11

Expected to finish

2030-07-01

Last updated by the study team

2026-05-08

Who can join

Age: any, up to 22. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University Children's Hospital Basel (UKBB) — Basel, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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