[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646817":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":60,"collaborators":10,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":10,"studyType":77,"phases":10,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":44,"whyStopped":10,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Papa Giovanni XXIII Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"flexible video-endoscopy",null,"Neonates undergoing surgical repair of tracheoesophageal fistula from October 2024 onwards, in whom preoperative airway assessment is performed by flexible video-endoscopy (Ambu aScope 5 Broncho 2.7\u002F1.2) under deep sedation with maintenance of spontaneous breathing and topical anesthesia of the upper airways and vocal cords.",[13],"Device: flexible video endoscopy of trachea",{"label":15,"type":10,"description":16,"interventionNames":17},"rigid tracheoscopy","All neonates who underwent surgical repair of tracheoesophageal fistula from January 2013 to September 2024, plus neonates undergoing surgical repair of tracheoesophageal fistula from October 2024 onwards, in whom preoperative airway assessment was performed by rigid optical tracheoscopy under general anesthesia with positive pressure ventilation.",[18],"Procedure: tracheoscopy performed with rigid optical tracheoscopy",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"PROCEDURE","tracheoscopy performed with rigid optical tracheoscopy","Rigid tracheoscopy is performed with rigid 3.0 or 3.5 mm optical device under general anesthesia and positive pressure ventilation",[15],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"DEVICE","flexible video endoscopy of trachea","Flexible tracheoscopy is performed with Ambu 2.7 flexible video-endoscopy under sedation in spontaneously breathing neonates",[9],[31],{"name":32,"affiliation":33,"role":34},"Ezio Bonanomi, MD","A.O. Ospedale Papa Giovanni XXIII","STUDY_CHAIR",[36],{"name":37,"role":38,"phone":39,"phoneExt":10,"email":40},"Stefano Mariconti, MD","CONTACT","+39 035.267.5150\u002F49","smariconti@asst-pg23.it",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":46,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Sc Ricerca Clinica, Sviluppo E Innovazione","RECRUITING","Bergamo","Italy","24100","IT",{"type":50,"coordinates":51},"Point",[52,53],9.66721,45.69601,{"lat":53,"lon":52},[56],{"name":57,"role":38,"phone":58,"phoneExt":10,"email":59},"Monia Lorini, Director","+39-035-2673341\u002F4432","mlorini@asst-pg23.it",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Stefano Mariconti","Consultant, MD","100646817","camera-based-endoscopy-allows-spontaneous-breathing-diagnostic-management-in-neonates-with-tracheoesophageal-fistula-100646817",false,"NCT07687628","Camera-based Endoscopy Allows Spontaneous Breathing Diagnostic Management in Neonates With Tracheoesophageal Fistula","CBESB","Inclusion Criteria:\n\n* Neonates who have undergone surgical repair of esophageal atresia with or without tracheoesophageal fistula at ASST Papa Giovanni XXIII, Bergamo, from 1 January 2013 onwards\n* Written informed consent signed by both parents or legal guardian\n\nExclusion Criteria:\n\n* Refusal or inability to obtain informed consent from parents or legal guardian","ALL","0 Days","28 Days",{"count":75,"type":76},60,"ESTIMATED","OBSERVATIONAL","The investigators aim to compare rigid tracheoscopy versus flexible tracheo-video-endoscopy in neonates requiring diagnostic assessment before undergoing a congenital tracheoesophageal fistula repair.",[80,81],"Tracheoesophageal Fistula","Esophageal Atresia With Tracheo-esophageal Fistula",[83],"tracheoesophageal fistula","2026-07-01",{"date":86,"type":87},"2026-07-07","ACTUAL",{"date":89,"type":87},"2024-10-01",{"date":91,"type":76},"2031-01-31",{"name":5,"class":6},1]