[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100397953":3},{"organization":4,"armGroups":7,"interventions":50,"overallOfficials":72,"centralContacts":76,"locations":85,"responsibleParty":115,"collaborators":117,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":125,"sex":131,"minAge":10,"maxAge":132,"enrollmentInfo":133,"targetDuration":10,"studyType":136,"phases":10,"briefSummary":137,"conditions":138,"keywords":142,"overallStatus":88,"whyStopped":10,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"University Children's Hospital Basel","OTHER",[8,15,18,21,24,29,32,35,38,41,44,47],{"label":9,"type":10,"description":10,"interventionNames":11},"obstructive bronchitis\u002Fbronchiolitis",null,[12,13,14],"Diagnostic Test: Real-time SESI-MS breath analysis","Diagnostic Test: Off-line breath analysis","Diagnostic Test: Blood analysis",{"label":16,"type":10,"description":10,"interventionNames":17},"pneumonia",[12,13,14],{"label":19,"type":10,"description":10,"interventionNames":20},"asthma",[12,13,14],{"label":22,"type":10,"description":10,"interventionNames":23},"neurological diseases",[12,13,14],{"label":25,"type":10,"description":10,"interventionNames":26},"type 1 diabetes (T1D)",[12,13,14,27,28],"Diagnostic Test: Saliva analysis","Diagnostic Test: Urine analysis",{"label":30,"type":10,"description":10,"interventionNames":31},"pharmacotherapy with bronchodilators",[12,13,14],{"label":33,"type":10,"description":10,"interventionNames":34},"pharmacotherapy with antibiotics",[12,13,14],{"label":36,"type":10,"description":10,"interventionNames":37},"pharmacotherapy with antiviral medication",[12,13,14],{"label":39,"type":10,"description":10,"interventionNames":40},"pharmacotherapy with antifungal medication",[12,13,14],{"label":42,"type":10,"description":10,"interventionNames":43},"pharmacotherapy with antiepileptic medication",[12,13,14],{"label":45,"type":10,"description":10,"interventionNames":46},"pharmacotherapy with immuno suppressants and immune-modulati",[12,13,14],{"label":48,"type":10,"description":10,"interventionNames":49},"pharmacotherapy with anesthesia (including sedating, analges",[12,13,14],[51,56,60,64,68],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":10},"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.",[19,22,9,48,33,42,39,36,30,45,16,25],{"type":52,"name":57,"description":58,"armGroupLabels":59,"otherNames":10},"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.",[19,22,9,48,33,42,39,36,30,45,16,25],{"type":52,"name":61,"description":62,"armGroupLabels":63,"otherNames":10},"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.",[19,22,9,48,33,42,39,36,30,45,16,25],{"type":52,"name":65,"description":66,"armGroupLabels":67,"otherNames":10},"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.",[25],{"type":52,"name":69,"description":70,"armGroupLabels":71,"otherNames":10},"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.",[25],[73],{"name":74,"affiliation":5,"role":75},"Pablo Sinues, Prof. Dr.","PRINCIPAL_INVESTIGATOR",[77,81],{"name":74,"role":78,"phone":79,"phoneExt":10,"email":80},"CONTACT","+41 61 704 2949","pablo.sinues@ukbb.ch",{"name":82,"role":78,"phone":83,"phoneExt":10,"email":84},"Mélina Richard","+41 61 704 14 11","melinadenise.richard@unibas.ch",[86],{"facility":87,"status":88,"city":89,"state":10,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"University Children's Hospital Basel (UKBB)","RECRUITING","Basel","4031","Switzerland","CH",{"type":94,"coordinates":95},"Point",[96,97],7.57327,47.55839,{"lat":97,"lon":96},[100,101,102,105,107,109,111,113],{"name":74,"role":78,"phone":79,"phoneExt":10,"email":80},{"name":82,"role":78,"phone":83,"phoneExt":10,"email":84},{"name":103,"role":104,"phone":10,"phoneExt":10,"email":10},"J Usemann, Dr. med.","SUB_INVESTIGATOR",{"name":106,"role":104,"phone":10,"phoneExt":10,"email":10},"U Fray, Prof. Dr. med.",{"name":108,"role":104,"phone":10,"phoneExt":10,"email":10},"A Datta, PD Dr. med.",{"name":110,"role":104,"phone":10,"phoneExt":10,"email":10},"G Szinnai, PD Dr. med.",{"name":112,"role":104,"phone":10,"phoneExt":10,"email":10},"A Jochmann, Dr. med.",{"name":114,"role":104,"phone":10,"phoneExt":10,"email":10},"T Erb, Prof. Dr. med.",{"type":116,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[118,120],{"name":119,"class":6},"Swiss National Science Foundation",{"name":121,"class":122},"Fondation Botnar (Switzerland)","UNKNOWN","100397953","exhaled-breath-analysis-by-secondary-electrospray-ionization---mass-spectrometry-in-children-and-adolescents-100397953",false,"NCT04461821","Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry in Children and Adolescents","Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry in Children and Adolescents (EBECA)","EBECA","Inclusion Criteria:\n\n* Age 0 ≤ 22 years at study entry and signed informed consent\n\nAdditional inclusion criteria for respiratory disease population:\n\n* 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.\n* Chronic disease: - Suspected or confirmed chronic airway disease (e.g. asthma).\n\nAdditional inclusion criteria for neurological disease population:\n\n* Acute disease: - Acute presentation or report within 24 hours of any signs of neurological deficit (motor function, sensoneural, or verbal).\n* Chronic disease: - Confirmed chronic neurologic disease (e.g. childhood epilepsy).\n\nAdditional inclusion criteria for T1D disease population:\n\n* Acute disease: - Hyperglycemia and\u002For pH (venous) \\\u003C7.3, bicarbonate \\>10 mmol\u002FL, increased levels of acetone in blood or urine in the context of newly diagnosed or known T1D.\n* Chronic disease: - Confirmed diagnosis of T1D\n\nExclusion Criteria:\n\n* Physical or intellectual impairment precluding protocol adherence.\n\nAdditional exclusion criteria for respiratory disease population:\n\n* Known malignancy, active smoker (passive smoke exposure is not an exclusion criterium), known inflammatory diseases (e.g. autoimmune disease) that require medical and\u002For pharmacological treatment and is associated with an inflammatory response, relevant congenital defects\n\nAdditional exclusion criteria for neurological disease population:\n\n* Known malignancy, active smoker (passive smoke exposure is not an exclusion criterium), known inflammatory diseases (e.g. autoimmune disease) that require medical and\u002For pharmacological treatment and is associated with an inflammatory response, relevant congenital defects.\n\nAdditional exclusion criteria for T1D population:\n\n* Known malignancy, active smoker (passive smoke exposure is not an exclusion criterium), relevant congenital defects.","ALL","22 Years",{"count":134,"type":135},3600,"ESTIMATED","OBSERVATIONAL","This study is to investigate breath analysis (breath metabolomics) combined with established bioinformatic tools as a platform for companion diagnostics.",[139,140,141],"Respiratory Diseases","Neurological Disorders","Type 1 Diabetes",[143,144,145,146,147],"Exhaled breath analysis","Therapeutic drug monitoring (TDM)","Secondary Electrospray ionization - mass spectrometry (SESI-MS)","breath analysis platform","breath metabolomics","2026-05-04",{"date":150,"type":151},"2026-05-08","ACTUAL",{"date":153,"type":151},"2020-09-11",{"date":155,"type":135},"2030-07",{"name":5,"class":6},1]