Analyzing exhaled breath in children and adolescents for better disease management

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the use of exhaled breath analysis combined with bioinformatic tools to enhance therapeutic drug monitoring (TDM) in children and adolescents. By utilizing a Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS) platform, the study aims to capture disease-related and drug-regulated metabolites from exhaled breath. This non-invasive approach seeks to provide personalized therapeutic management by correlating breath analysis data with standard clinical measures. The study focuses on patients with respiratory diseases, neurological disorders, and Type 1 diabetes.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Pablo Sinues, Prof. Dr. — University Children's Hospital Basel
• Study coordinator: Pablo Sinues, Prof. Dr.
• Email: pablo.sinues@ukbb.ch
• Phone: +41 61 704 2949

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.