An observational study in Respiratory Diseases, Neurological Disorders and Type 1 Diabetes, sponsored by University Children's Hospital Basel. Recruiting at 1 site in Switzerland. Open to participants aged Up to 22 Years. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by University Children's Hospital Basel · Observational
This study is to investigate breath analysis (breath metabolomics) combined with established bioinformatic tools as a platform for companion diagnostics.
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 to achieve maximum efficacy and at the same time minimize toxicity. The concept of TDM could potentially be even more valuable if in addition to drug concentrations, other drug-regulated and drug-related metabolites could be included in the models to define optimal dosage. There exists a clinical need to stratify patients with better precision to improve current clinical and therapeutic management. Breath analysis offers an opportunity to non-invasively retrieve relevant information on the ongoing internal biochemical processes, as well as to monitor the respiratory system itself. For breath analysis, a Secondary Electrospray ionization - mass spectrometry (SESI-MS) breath analysis platform will be used to capture disease-related, drug-regulated and drug-related metabolites (breath metabolomics) in exhaled breath. This information, retrieved in parallel to standard of care clinical co-variates, could have the potential to provide a more personalized therapeutic management of patients.
617 studies on the registry are indexed under Respiratory Tract Diseases; 111 are open to participants now.
This study's planned enrollment of 3,600 is above the median of 294 across 216 observational studies indexed under Respiratory Tract Diseases.
Browse Respiratory Tract Diseases studies →University Children's Hospital Basel is the lead sponsor of 27 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants presenting with an acute disease in the emergency department at the University of Basel Children's Hospital (UKBB).
Participants with chronic diseases recorded at the University of Basel Children's Hospital (UKBB).
Additional inclusion criteria for respiratory disease population:
Additional inclusion criteria for neurological disease population:
Additional inclusion criteria for T1D disease population:
Exclusion Criteria:
Additional exclusion criteria for respiratory disease population:
Additional exclusion criteria for neurological disease population:
Additional exclusion criteria for T1D population:
Diagnostic Test: Real-time SESI-MS breath analysis · Diagnostic Test: Off-line breath analysis · Diagnostic Test: Blood analysis
Diagnostic Test: Real-time SESI-MS breath analysis · Diagnostic Test: Off-line breath analysis · Diagnostic Test: Blood analysis
Diagnostic Test: Real-time SESI-MS breath analysis · Diagnostic Test: Off-line breath analysis · Diagnostic Test: Blood analysis
Diagnostic Test: Real-time SESI-MS breath analysis · Diagnostic Test: Off-line breath analysis · Diagnostic Test: Blood analysis
Diagnostic Test: Real-time SESI-MS breath analysis · Diagnostic Test: Off-line breath analysis · Diagnostic Test: Blood analysis · Diagnostic Test: Saliva analysis · Diagnostic Test: Urine analysis
Diagnostic Test: Real-time SESI-MS breath analysis · Diagnostic Test: Off-line breath analysis · Diagnostic Test: Blood analysis
Diagnostic Test: Real-time SESI-MS breath analysis · Diagnostic Test: Off-line breath analysis · Diagnostic Test: Blood analysis
Diagnostic Test: Real-time SESI-MS breath analysis · Diagnostic Test: Off-line breath analysis · Diagnostic Test: Blood analysis
Diagnostic Test: Real-time SESI-MS breath analysis · Diagnostic Test: Off-line breath analysis · Diagnostic Test: Blood analysis
Diagnostic Test: Real-time SESI-MS breath analysis · Diagnostic Test: Off-line breath analysis · Diagnostic Test: Blood analysis
Diagnostic Test: Real-time SESI-MS breath analysis · Diagnostic Test: Off-line breath analysis · Diagnostic Test: Blood analysis
Diagnostic Test: Real-time SESI-MS breath analysis · Diagnostic Test: Off-line breath analysis · Diagnostic Test: Blood analysis
Participants will be asked to refrain from eating, drinking, chewing gum use or brushing their teeth at least 1 hour before the measurements will be performed. Room temperature and lighting will be set at the same level for all measurements. Participants will exhale through a disposable mouthpiece into a commercially available SESI source (FIT S.L., Spain). While performing full exhalations, the subjects will keep the pressure through the sampling line at a fixed value monitored by a digital manometer. Breath prints will be collected in real-time recording multiple replicates (typically six in positive and negative ion mode). The whole procedure is absolutely non-invasive and is usually accomplished without any effort in around 15 min per subject.
In young children below the age of 4 not capable of completing the on-line exhalation maneuvers, or in cases when the patient needs cannot approach the mass spectrometer, the sample will be collected off-line. They will be asked to exhale into a bag that will be transported to the lab and deflated into the mass spectrometer for analysis. Exhaled breath of patients under anesthesia will also collected using available ventilation system in the operation theatre.
Blood analysis done in patients who undergo regular blood sampling needed for clinical routine laboratory controls. This includes i) children and adolescents receiving medications which require TDM ii) patients with acute diseases such as TD1 and pneumonia and iii) patients with chronic diseases such as asthma bronchiale. For those patients where a blood sample is drawn during the clinical routine, an additional blood sample consisting of only several blood drops will be collected using the same blood sampling line. No additional venous puncture for research purpose will be done.
During the diagnostic and therapeutic work-up of T1D patients, saliva samples are collected during the clinical routine. For those patients, additional samples will be obtained by clinically trained investigators.
During the diagnostic and therapeutic work-up of T1D patients, urine samples are collected during the clinical routine. For those patients, additional samples will be obtained by clinically trained investigators.
Days of hospitalization
In the presentation of an acute disease the primary outcome will be days of hospitalization and its association with the exhaled breath pattern.
Time frame: approx 30 days (from beginn hospitalisation to discharge date)
Change in Mass spectrometric profile of exhaled breath patterns
In the chronic presentation of the diseases, the mass spectrometric profile of exhaled breath patterns is analyzed
Time frame: Week 0 (first regular clinic visit) to Follow-up visits (approx. years 1-10)
Change in Concentration of exhaled metabolites of pharmacotherapy
Concentration of exhaled metabolites of pharmacotherapy (breath metabolomics data)
Time frame: Week 0 (first regular clinic visit) to Follow-up visits (approx. years 1-10)
Identification of chemical structure of exhaled molecules (acetone, glucose)
Identification of chemical structure of exhaled molecules (acetone, glucose)
Time frame: approx 30 days (from begin hospitalisation to discharge date)
Correlations of identified molecules (acetone, glucose) in exhaled breath with body fluids (blood, saliva, urine) for T1D acute disease (mmol/l)
Correlations of identified molecules (acetone, glucose) in exhaled breath with body fluids (blood, saliva, urine) for T1D acute disease (mmol/l)
Time frame: 0h, 2h, 4h, 6h, 8h, 12h, 18h, 24h, 36h, 48h, 72h (h =hours after hospital admission)
Change in clinical endpoint lung function (Forced Expiratory Pressure in 1 Second FEV1 l/s) for correlation between clinical endpoint and the abundance of exhaled metabolites
Change in clinical endpoint lung function (Forced Expiratory Pressure in 1 Second FEV1 l/s) for correlation between clinical endpoint and the abundance of exhaled metabolites
Time frame: approx 10 years (from begin hospitalisation to discharge date and from first regular clinic visit to Follow-up visits)
Change in clinical endpoint (body temperature, Celsius) for correlation between clinical endpoint and the abundance of exhaled metabolites
Change in clinical endpoint (body temperature) for correlation between clinical endpoint and the abundance of exhaled metabolites
Time frame: approx 10 years (from begin hospitalisation to discharge date and from first regular clinic visit to Follow-up visits)
Change in clinical endpoint (blood pressure, mmHg) for correlation between clinical endpoint and the abundance of exhaled metabolites
Change in clinical endpoint (blood pressure) for correlation between clinical endpoint and the abundance of exhaled metabolites
Time frame: approx 10 years (from begin hospitalisation to discharge date and from first regular clinic visit to Follow-up visits)
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University Children's Hospital Basel