<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04461821</url>
  </required_header>
  <id_info>
    <org_study_id>2020-00778; ks20Sinues</org_study_id>
    <nct_id>NCT04461821</nct_id>
  </id_info>
  <brief_title>Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry in Children and Adolescents</brief_title>
  <acronym>EBECA</acronym>
  <official_title>Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry in Children and Adolescents (EBECA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Children's Hospital Basel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swiss National Science Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fondation Botnar (Switzerland)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Children's Hospital Basel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to investigate breath analysis (breath metabolomics) combined with established&#xD;
      bioinformatic tools as a platform for companion diagnostics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Therapeutic drug monitoring (TDM) is defined as measuring concentrations of a drug at one or&#xD;
      more time points in a biological matrix after a dose. The purpose of TDM is to individualize&#xD;
      the drug dose to achieve maximum efficacy and at the same time minimize toxicity. The concept&#xD;
      of TDM could potentially be even more valuable if in addition to drug concentrations, other&#xD;
      drug-regulated and drug-related metabolites could be included in the models to define optimal&#xD;
      dosage. There exists a clinical need to stratify patients with better precision to improve&#xD;
      current clinical and therapeutic management. Breath analysis offers an opportunity to&#xD;
      non-invasively retrieve relevant information on the ongoing internal biochemical processes,&#xD;
      as well as to monitor the respiratory system itself. For breath analysis, a Secondary&#xD;
      Electrospray ionization - mass spectrometry (SESI-MS) breath analysis platform will be used&#xD;
      to capture disease-related, drug-regulated and drug-related metabolites (breath metabolomics)&#xD;
      in exhaled breath. This information, retrieved in parallel to standard of care clinical&#xD;
      co-variates, could have the potential to provide a more personalized therapeutic management&#xD;
      of patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 11, 2020</start_date>
  <completion_date type="Anticipated">July 2030</completion_date>
  <primary_completion_date type="Anticipated">July 2030</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Days of hospitalization</measure>
    <time_frame>approx 30 days (from beginn hospitalisation to discharge date)</time_frame>
    <description>In the presentation of an acute disease the primary outcome will be days of hospitalization and its association with the exhaled breath pattern.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Mass spectrometric profile of exhaled breath patterns</measure>
    <time_frame>Week 0 (first regular clinic visit) to Follow-up visits (approx. years 1-10)</time_frame>
    <description>In the chronic presentation of the diseases, the mass spectrometric profile of exhaled breath patterns is analyzed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Concentration of exhaled metabolites of pharmacotherapy</measure>
    <time_frame>Week 0 (first regular clinic visit) to Follow-up visits (approx. years 1-10)</time_frame>
    <description>Concentration of exhaled metabolites of pharmacotherapy (breath metabolomics data)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identification of chemical structure of exhaled molecules (acetone, glucose)</measure>
    <time_frame>approx 30 days (from begin hospitalisation to discharge date)</time_frame>
    <description>Identification of chemical structure of exhaled molecules (acetone, glucose)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlations of identified molecules (acetone, glucose) in exhaled breath with body fluids (blood, saliva, urine) for T1D acute disease (mmol/l)</measure>
    <time_frame>0h, 2h, 4h, 6h, 8h, 12h, 18h, 24h, 36h, 48h, 72h (h =hours after hospital admission)</time_frame>
    <description>Correlations of identified molecules (acetone, glucose) in exhaled breath with body fluids (blood, saliva, urine) for T1D acute disease (mmol/l)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>approx 10 years (from begin hospitalisation to discharge date and from first regular clinic visit to Follow-up visits)</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in clinical endpoint (body temperature, Celsius) for correlation between clinical endpoint and the abundance of exhaled metabolites</measure>
    <time_frame>approx 10 years (from begin hospitalisation to discharge date and from first regular clinic visit to Follow-up visits)</time_frame>
    <description>Change in clinical endpoint (body temperature) for correlation between clinical endpoint and the abundance of exhaled metabolites</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in clinical endpoint (blood pressure, mmHg) for correlation between clinical endpoint and the abundance of exhaled metabolites</measure>
    <time_frame>approx 10 years (from begin hospitalisation to discharge date and from first regular clinic visit to Follow-up visits)</time_frame>
    <description>Change in clinical endpoint (blood pressure) for correlation between clinical endpoint and the abundance of exhaled metabolites</description>
  </secondary_outcome>
  <number_of_groups>12</number_of_groups>
  <enrollment type="Anticipated">3600</enrollment>
  <condition>Respiratory Diseases</condition>
  <condition>Neurological Disorders</condition>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>obstructive bronchitis/bronchiolitis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>pneumonia</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>asthma</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>neurological diseases</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>type 1 diabetes (T1D)</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>pharmacotherapy with bronchodilators</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>pharmacotherapy with antibiotics</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>pharmacotherapy with antiviral medication</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>pharmacotherapy with antifungal medication</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>pharmacotherapy with antiepileptic medication</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>pharmacotherapy with immuno suppressants and immune-modulati</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>pharmacotherapy with anesthesia (including sedating, analges</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Real-time SESI-MS breath analysis</intervention_name>
    <description>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.</description>
    <arm_group_label>asthma</arm_group_label>
    <arm_group_label>neurological diseases</arm_group_label>
    <arm_group_label>obstructive bronchitis/bronchiolitis</arm_group_label>
    <arm_group_label>pharmacotherapy with anesthesia (including sedating, analges</arm_group_label>
    <arm_group_label>pharmacotherapy with antibiotics</arm_group_label>
    <arm_group_label>pharmacotherapy with antiepileptic medication</arm_group_label>
    <arm_group_label>pharmacotherapy with antifungal medication</arm_group_label>
    <arm_group_label>pharmacotherapy with antiviral medication</arm_group_label>
    <arm_group_label>pharmacotherapy with bronchodilators</arm_group_label>
    <arm_group_label>pharmacotherapy with immuno suppressants and immune-modulati</arm_group_label>
    <arm_group_label>pneumonia</arm_group_label>
    <arm_group_label>type 1 diabetes (T1D)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Off-line breath analysis</intervention_name>
    <description>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.</description>
    <arm_group_label>asthma</arm_group_label>
    <arm_group_label>neurological diseases</arm_group_label>
    <arm_group_label>obstructive bronchitis/bronchiolitis</arm_group_label>
    <arm_group_label>pharmacotherapy with anesthesia (including sedating, analges</arm_group_label>
    <arm_group_label>pharmacotherapy with antibiotics</arm_group_label>
    <arm_group_label>pharmacotherapy with antiepileptic medication</arm_group_label>
    <arm_group_label>pharmacotherapy with antifungal medication</arm_group_label>
    <arm_group_label>pharmacotherapy with antiviral medication</arm_group_label>
    <arm_group_label>pharmacotherapy with bronchodilators</arm_group_label>
    <arm_group_label>pharmacotherapy with immuno suppressants and immune-modulati</arm_group_label>
    <arm_group_label>pneumonia</arm_group_label>
    <arm_group_label>type 1 diabetes (T1D)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood analysis</intervention_name>
    <description>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.</description>
    <arm_group_label>asthma</arm_group_label>
    <arm_group_label>neurological diseases</arm_group_label>
    <arm_group_label>obstructive bronchitis/bronchiolitis</arm_group_label>
    <arm_group_label>pharmacotherapy with anesthesia (including sedating, analges</arm_group_label>
    <arm_group_label>pharmacotherapy with antibiotics</arm_group_label>
    <arm_group_label>pharmacotherapy with antiepileptic medication</arm_group_label>
    <arm_group_label>pharmacotherapy with antifungal medication</arm_group_label>
    <arm_group_label>pharmacotherapy with antiviral medication</arm_group_label>
    <arm_group_label>pharmacotherapy with bronchodilators</arm_group_label>
    <arm_group_label>pharmacotherapy with immuno suppressants and immune-modulati</arm_group_label>
    <arm_group_label>pneumonia</arm_group_label>
    <arm_group_label>type 1 diabetes (T1D)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Saliva analysis</intervention_name>
    <description>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.</description>
    <arm_group_label>type 1 diabetes (T1D)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Urine analysis</intervention_name>
    <description>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.</description>
    <arm_group_label>type 1 diabetes (T1D)</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples will be divided into two sets and stored at -80°C in a dedicated, lock-secured&#xD;
      laboratory freezer for later molecular analysis. One set will be used for blood plasma&#xD;
      metabolomics. A second set will be analyzed depending on the exploratory findings regarding&#xD;
      breath compounds. These samples shall enable retrospective correlation between the&#xD;
      concentrations of molecules-of-interest in breath and blood.&#xD;
&#xD;
      Saliva and urine samples will be divided in two sets and stored at -80°C in a dedicated,&#xD;
      lock-secured laboratory freezer for later molecular analysis. One set will be used for&#xD;
      metabolomics. A second set will be analyzed depending on the exploratory findings regarding&#xD;
      breath compounds. These samples shall enable retrospective correlation between the&#xD;
      concentrations of molecules-of-interest in breath and saliva.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Participants presenting with an acute disease in the emergency department at the University&#xD;
        of Basel Children's Hospital (UKBB).&#xD;
&#xD;
        Participants with chronic diseases recorded at the University of Basel Children's Hospital&#xD;
        (UKBB).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 0 ≤ 22 years at study entry and signed informed consent&#xD;
&#xD;
        Additional inclusion criteria for respiratory disease population:&#xD;
&#xD;
          -  Acute disease: - Acute signs for a respiratory disease, indicated by e.g. increased&#xD;
             work of breathing (e.g. dyspnea, increased respiratory rate), cough or wheezing.&#xD;
&#xD;
          -  Chronic disease: - Suspected or confirmed chronic airway disease (e.g. asthma).&#xD;
&#xD;
        Additional inclusion criteria for neurological disease population:&#xD;
&#xD;
          -  Acute disease: - Acute presentation or report within 24 hours of any signs of&#xD;
             neurological deficit (motor function, sensoneural, or verbal).&#xD;
&#xD;
          -  Chronic disease: - Confirmed chronic neurologic disease (e.g. childhood epilepsy).&#xD;
&#xD;
        Additional inclusion criteria for T1D disease population:&#xD;
&#xD;
          -  Acute disease: - Hyperglycemia and/or pH (venous) &lt;7.3, bicarbonate &gt;10 mmol/L,&#xD;
             increased levels of acetone in blood or urine in the context of newly diagnosed or&#xD;
             known T1D.&#xD;
&#xD;
          -  Chronic disease: - Confirmed diagnosis of T1D&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Physical or intellectual impairment precluding protocol adherence.&#xD;
&#xD;
        Additional exclusion criteria for respiratory disease population:&#xD;
&#xD;
          -  Known malignancy, active smoker (passive smoke exposure is not an exclusion&#xD;
             criterium), known inflammatory diseases (e.g. autoimmune disease) that require medical&#xD;
             and/or pharmacological treatment and is associated with an inflammatory response,&#xD;
             relevant congenital defects&#xD;
&#xD;
        Additional exclusion criteria for neurological disease population:&#xD;
&#xD;
          -  Known malignancy, active smoker (passive smoke exposure is not an exclusion&#xD;
             criterium), known inflammatory diseases (e.g. autoimmune disease) that require medical&#xD;
             and/or pharmacological treatment and is associated with an inflammatory response,&#xD;
             relevant congenital defects.&#xD;
&#xD;
        Additional exclusion criteria for T1D population:&#xD;
&#xD;
          -  Known malignancy, active smoker (passive smoke exposure is not an exclusion&#xD;
             criterium), relevant congenital defects.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>22 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pablo Sinues, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Children's Hospital Basel, UKBB</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pablo Sinues, Prof. Dr.</last_name>
    <phone>+41 61 704 2949</phone>
    <email>pablo.sinues@ukbb.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mélina Richard</last_name>
    <phone>+41 61 704 14 11</phone>
    <email>melinadenise.richard@unibas.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Children's Hospital Basel (UKBB)</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pablo Sinues, Prof. Dr.</last_name>
      <phone>+41 61 704 2949</phone>
      <email>pablo.sinues@ukbb.ch</email>
    </contact>
    <contact_backup>
      <last_name>Mélina Richard</last_name>
      <phone>+41 61 704 14 11</phone>
      <email>melinadenise.richard@unibas.ch</email>
    </contact_backup>
    <investigator>
      <last_name>J Usemann, Dr. med.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>U Fray, Prof. Dr. med.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>A Datta, PD Dr. med.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>G Szinnai, PD Dr. med.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>A Jochmann, Dr. med.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>T Erb, Prof. Dr. med.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>December 10, 2021</last_update_submitted>
  <last_update_submitted_qc>December 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exhaled breath analysis</keyword>
  <keyword>Therapeutic drug monitoring (TDM)</keyword>
  <keyword>Secondary Electrospray ionization - mass spectrometry (SESI-MS)</keyword>
  <keyword>breath analysis platform</keyword>
  <keyword>breath metabolomics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Tract Diseases</mesh_term>
    <mesh_term>Respiration Disorders</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04461821
org study id: 2020-00778; ks20Sinues
nct id: NCT04461821
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
measure: Days of hospitalization
time frame: approx 30 days (from beginn hospitalisation to discharge date)
description: In the presentation of an acute disease the primary outcome will be days of hospitalization and its association with the exhaled breath pattern.
measure: Change in Mass spectrometric profile of exhaled breath patterns
time frame: Week 0 (first regular clinic visit) to Follow-up visits (approx. years 1-10)
description: In the chronic presentation of the diseases, the mass spectrometric profile of exhaled breath patterns is analyzed
measure: Change in Concentration of exhaled metabolites of pharmacotherapy
time frame: Week 0 (first regular clinic visit) to Follow-up visits (approx. years 1-10)
description: Concentration of exhaled metabolites of pharmacotherapy (breath metabolomics data)
measure: Identification of chemical structure of exhaled molecules (acetone, glucose)
time frame: approx 30 days (from begin hospitalisation to discharge date)
description: Identification of chemical structure of exhaled molecules (acetone, glucose)
measure: 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)
description: Correlations of identified molecules (acetone, glucose) in exhaled breath with body fluids (blood, saliva, urine) for T1D acute disease (mmol/l)
measure: 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)
description: 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
measure: Change in clinical endpoint (body temperature, Celsius) 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)
description: Change in clinical endpoint (body temperature) for correlation between clinical endpoint and the abundance of exhaled metabolites
measure: Change in clinical endpoint (blood pressure, mmHg) 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)
description: Change in clinical endpoint (blood pressure) for correlation between clinical endpoint and the abundance of exhaled metabolites
arm group label: obstructive bronchitis/bronchiolitis
arm group label: pneumonia
arm group label: asthma
arm group label: neurological diseases
arm group label: type 1 diabetes (T1D)
arm group label: pharmacotherapy with bronchodilators
arm group label: pharmacotherapy with antibiotics
arm group label: pharmacotherapy with antiviral medication
arm group label: pharmacotherapy with antifungal medication
arm group label: pharmacotherapy with antiepileptic medication
arm group label: pharmacotherapy with immuno suppressants and immune-modulati
arm group label: pharmacotherapy with anesthesia (including sedating, analges
intervention type: Diagnostic Test
intervention name: Real-time SESI-MS breath analysis
description: 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.
arm group label: asthma
arm group label: neurological diseases
arm group label: obstructive bronchitis/bronchiolitis
arm group label: pharmacotherapy with anesthesia (including sedating, analges
arm group label: pharmacotherapy with antibiotics
arm group label: pharmacotherapy with antiepileptic medication
arm group label: pharmacotherapy with antifungal medication
arm group label: pharmacotherapy with antiviral medication
arm group label: pharmacotherapy with bronchodilators
arm group label: pharmacotherapy with immuno suppressants and immune-modulati
arm group label: pneumonia
arm group label: type 1 diabetes (T1D)
intervention type: Diagnostic Test
intervention name: Off-line breath analysis
description: 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.
arm group label: asthma
arm group label: neurological diseases
arm group label: obstructive bronchitis/bronchiolitis
arm group label: pharmacotherapy with anesthesia (including sedating, analges
arm group label: pharmacotherapy with antibiotics
arm group label: pharmacotherapy with antiepileptic medication
arm group label: pharmacotherapy with antifungal medication
arm group label: pharmacotherapy with antiviral medication
arm group label: pharmacotherapy with bronchodilators
arm group label: pharmacotherapy with immuno suppressants and immune-modulati
arm group label: pneumonia
arm group label: type 1 diabetes (T1D)
intervention type: Diagnostic Test
intervention name: Blood analysis
description: 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.
arm group label: asthma
arm group label: neurological diseases
arm group label: obstructive bronchitis/bronchiolitis
arm group label: pharmacotherapy with anesthesia (including sedating, analges
arm group label: pharmacotherapy with antibiotics
arm group label: pharmacotherapy with antiepileptic medication
arm group label: pharmacotherapy with antifungal medication
arm group label: pharmacotherapy with antiviral medication
arm group label: pharmacotherapy with bronchodilators
arm group label: pharmacotherapy with immuno suppressants and immune-modulati
arm group label: pneumonia
arm group label: type 1 diabetes (T1D)
intervention type: Diagnostic Test
intervention name: Saliva analysis
description: 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.
arm group label: type 1 diabetes (T1D)
intervention type: Diagnostic Test
intervention name: Urine analysis
description: 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.
arm group label: type 1 diabetes (T1D)
Blood samples will be divided into two sets and stored at -80°C in a dedicated, lock-secured
      laboratory freezer for later molecular analysis. One set will be used for blood plasma
      metabolomics. A second set will be analyzed depending on the exploratory findings regarding
      breath compounds. These samples shall enable retrospective correlation between the
      concentrations of molecules-of-interest in breath and blood.

      Saliva and urine samples will be divided in two sets and stored at -80°C in a dedicated,
      lock-secured laboratory freezer for later molecular analysis. One set will be used for
      metabolomics. A second set will be analyzed depending on the exploratory findings regarding
      breath compounds. These samples shall enable retrospective correlation between the
      concentrations of molecules-of-interest in breath and saliva.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 22 Years
healthy volunteers: No
last name: Pablo Sinues, Prof. Dr.
role: Principal Investigator
affiliation: University Children's Hospital Basel, UKBB
last name: Pablo Sinues, Prof. Dr.
phone: +41 61 704 2949
email: pablo.sinues@ukbb.ch
last name: Mélina Richard
phone: +41 61 704 14 11
email: melinadenise.richard@unibas.ch
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Switzerland
responsible party type: Sponsor
mesh term: Respiratory Tract Diseases
mesh term: Respiration Disorders
mesh term: Nervous System Diseases