[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100329603":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":12,"centralContacts":22,"locations":31,"responsibleParty":61,"collaborators":64,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":87,"studyType":88,"phases":7,"briefSummary":89,"conditions":90,"keywords":7,"overallStatus":34,"whyStopped":7,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",null,[9],{"type":6,"name":10,"description":11,"armGroupLabels":7,"otherNames":7},"No intervention","No intervention due to the observational set-up of this study.",[13,16,19],{"name":14,"affiliation":5,"role":15},"Lissy de Ridder, Professor, MD","PRINCIPAL_INVESTIGATOR",{"name":17,"affiliation":18,"role":15},"Nicholas Croft, Professor, MD","Barts and the London School of Medicine, Queen Mary University of London",{"name":20,"affiliation":21,"role":15},"Frank Ruemmele, Professor, MD","Hopital Necker-Enfants Malades, Paris",[23,27],{"name":14,"role":24,"phone":25,"phoneExt":7,"email":26},"CONTACT","+31715262824","l.deridder@erasmusmc.nl",{"name":28,"role":24,"phone":29,"phoneExt":7,"email":30},"Nick M. Croft, Professor, MD","+44 20 7882 2642","n.m.croft@qmul.ac.uk",[32,48],{"facility":33,"status":34,"city":35,"state":7,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Erasmus MC - Sophia Children's Hospital","RECRUITING","Rotterdam","3015GD","Netherlands","NL",{"type":40,"coordinates":41},"Point",[42,43],4.47917,51.9225,{"lat":43,"lon":42},[46],{"name":47,"role":24,"phone":7,"phoneExt":7,"email":26},"Lissy De Ridder, MD, PhD",{"facility":49,"status":34,"city":50,"state":7,"zip":7,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Royal Hospital London","London","United Kingdom","UK",{"type":40,"coordinates":54},[55,56],-0.12574,51.50853,{"lat":56,"lon":55},[59],{"name":60,"role":24,"phone":7,"phoneExt":7,"email":30},"Nicholas Croft, MD, PhD",{"type":15,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Lissy de Ridder","Professor of Pediatrics, Pediatric Gastroenterologist",[65,67,69],{"name":66,"class":6},"European Commission",{"name":68,"class":6},"Queen Mary University of London",{"name":70,"class":71},"Hôpital Necker-Enfants Malades, Paris","UNKNOWN","100329603","pibd-setquality-the-inception-cohort-and-safety-registry-100329603",false,"NCT03571373","PIBD-SETQuality: the Inception Cohort and Safety Registry","Paediatric Inflammatory Bowel Diseases Network for Safety, Efficacy, Treatment and Quality Improvement of Care: The PIBD-NET Inception Cohort and Safety Registry","PIBD-SETQ","Inclusion Criteria Inception cohort:\n\nNewly diagnosed patient, \\\u003C18 years of age, with a likely diagnosis of IBD or a confirmed diagnosis of IBD can be included in the study. In order to be eligible to continue in the study the subject must meet all of the following criteria:\n\n* Diagnosis is based on history, physical examination, laboratory, endoscopic, radiological and histological features according to the revised Porto criteria (1)\n* Diagnosis has been made or is confirmed within 2 months of inclusion\n* Data on all diagnostic procedures are available for inclusion in the database\n* Informed consent of patient (if indicated) and parents has been obtained\n* Concerning the patients of whom biological specimens will be included: patients have not started IBD treatment yet\n\nInclusion Criteria Safety Registry:\n\nAny child with IBD \\\u003C19 years old with complications as detailed in the agreed safety monitoring list (or future updates of the list of conditions) can be reported. For the initial reporting of incident cases no patient identifiable details will be required.\n\nExclusion Criteria Inception cohort:\n\n* Inability to read and understand the patient and family information sheets (for example insufficient knowledge of national language, where no health advocate or family member is available to translate and ensure full understanding of the study)\n* Informed consent of patient or parents has not been obtained when required\n* Patients on similar treatments as for IBD but for other conditions, or known with conditions directly affecting the IBD (e.g. immunodeficiency or major gastrointestinal resections)\n\nExclusion Criteria Safety registry: none.",true,"ALL","0 Years","19 Years",{"count":85,"type":86},1500,"ESTIMATED","20 Years","OBSERVATIONAL","The purpose of this study is to analyse effectiveness and safety signals of current treatment strategies in routine practice for patients with pediatric-onset inflammatory bowel disease (PIBD) and to correlate this to their individual risk factors.",[91,92,93],"Inflammatory Bowel Diseases","Crohn Disease","Ulcerative Colitis","2026-08-07",{"date":96,"type":97},"2026-08-11","ACTUAL",{"date":99,"type":97},"2017-01-03",{"date":101,"type":86},"2030-12-31",{"name":5,"class":6},2]