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

Summary

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

Conditions

• Respiratory Diseases
• Neurological Disorders
• Type 1 Diabetes

Interventions

DIAGNOSTIC_TEST

Real-time SESI-MS breath 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.

DIAGNOSTIC_TEST

Off-line breath analysis

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.

DIAGNOSTIC_TEST

Blood analysis

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.

DIAGNOSTIC_TEST

Saliva analysis

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.

DIAGNOSTIC_TEST

Urine analysis

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.

Sponsors & Collaborators

• Swiss National Science Foundation

  collaborator OTHER

• Fondation Botnar (Switzerland)

  collaborator UNKNOWN

• University Children's Hospital Basel

  lead OTHER

Principal Investigators

• Pablo Sinues, Prof. Dr. · University Children's Hospital Basel

Eligibility

Max Age

22 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-11

Primary Completion

2030-07-31

Completion

2030-07-31

Countries

• Switzerland

Study Locations