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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Up to 22 years
• All sexes
• No healthy volunteers
• Child, Adult

Study population: 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry in Children and Adolescents (EBECA)

Conditions

Respiratory Diseases, Neurological Disorders, Type 1 Diabetes

Being tested

Real-time SESI-MS breath analysis, Off-line breath analysis, Blood analysis, Saliva analysis, Urine analysis

Keywords

Exhaled breath analysis, Therapeutic drug monitoring (TDM), Secondary Electrospray ionization - mass spectrometry (SESI-MS), breath analysis platform, breath metabolomics

Medical subject headings

Respiratory Tract Diseases, Nervous System Diseases, Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Real-time SESI-MS breath analysisDiagnostic test

  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.

• Off-line breath analysisDiagnostic test

  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 analysisDiagnostic test

  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.

• Saliva analysisDiagnostic test

  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.

• Urine analysisDiagnostic test

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: approx 30 days (from beginn hospitalisation to discharge date)

2. 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

   Measured: Week 0 (first regular clinic visit) to Follow-up visits (approx. years 1-10)

3. Change in Concentration of exhaled metabolites of pharmacotherapy

   Concentration of exhaled metabolites of pharmacotherapy (breath metabolomics data)

   Measured: Week 0 (first regular clinic visit) to Follow-up visits (approx. years 1-10)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted8 Jul 2020
2. Study start11 Sep 2020
3. Primary completionJul 2030 (estimated)
4. Study completionJul 2030 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Respiratory DiseasesStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.