Analyzing exhaled breath in children and adolescents for better disease management
Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry in Children and Adolescents (EBECA)
This study is testing if analyzing breath samples can help doctors better manage treatment for children and teens with respiratory diseases, neurological disorders, and Type 1 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3600 (estimated) |
| Ages | N/A to 22 Years |
| Sex | All |
| Sponsor | University Children's Hospital Basel Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT04461821 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include children and adolescents aged 0 to 22 years with acute or chronic respiratory diseases, neurological disorders, or Type 1 diabetes.
Not a fit: Patients with conditions not related to respiratory diseases, neurological disorders, or Type 1 diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment strategies for children and adolescents with various health conditions.
How similar studies have performed: While the use of breath analysis for diagnostics is an emerging field, similar studies have shown promise in utilizing breath metabolomics for disease monitoring.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Basel
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.