[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100325915":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":56,"collaborators":24,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":24,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":24,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":41,"whyStopped":24,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Hamad Medical Corporation","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dexamethasone arm","ACTIVE_COMPARATOR","All patients will be Urgently treated for anaphylaxis according to guideline protocol. Enrolled patients will be given one of study medication orally, and he \u002Fshe will observe in the observation room with cardiac monitor and close monitoring by nurse.",[13],"Drug: Dexamethasone Oral",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo arm","PLACEBO_COMPARATOR",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Dexamethasone Oral","use of one dose of Dexamethasone orally.or placebo in addition to regular treatment of anaphylaxis",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"Khalid Al ansari, FRCP","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Rafah Sayyed, Md","CONTACT","+974-55747045","ralsayyed@hamad.qa",{"name":36,"role":32,"phone":37,"phoneExt":24,"email":38},"Khalid Al Ansari, FRCP","+97444396006","kalansari1@hmc.org.qa",[40],{"facility":5,"status":41,"city":42,"state":24,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Doha","3050","Qatar","QA",{"type":47,"coordinates":48},"Point",[49,50],51.53096,25.28545,{"lat":50,"lon":49},[53],{"name":54,"role":32,"phone":55,"phoneExt":24,"email":34},"Rafah Sayyed, MD","+97455747045",{"type":28,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"DR. KHALID AL-ANSARI","Director of Pediatrics Emergency Centeres","100325915","phase-1-use-of-dexamethasone-in-prevention-of-the-second-phase-or-a-biphasic-reaction-of-anaphylaxis-100325915",false,"NCT03523221","Use of Dexamethasone in Prevention of the Second Phase or a Biphasic Reaction of Anaphylaxis","Inclusion Criteria:\n\n* All patients 3 monthes-14years presenting to the Pediatric Emergency Department (AlSadd) with mild to moderate anaphylaxis\n\nExclusion Criteria:\n\nPatients with severe anaphylaxis. Patient with history of immunological diseases. Patients on steroids therapy Patient with moderate-severe asthma on medication Patients with severe asthma",true,"ALL","3 Months","14 Years",{"count":70,"type":71},210,"ESTIMATED","INTERVENTIONAL",[74],"PHASE1","Anaphylaxis is an acute serious allergic reaction, with multi-organ system manifestations caused by the release of chemical mediators and it is potentially fatal .\n\nBetween 5% and 14% of patients may experience a recurrence of anaphylaxis 8-12 hours after the initial presentation, called biphasic (late-phase) .\n\nThe mainstay of treatment for children experiencing anaphylaxis remains adrenaline and H1-antihistamines. Corticosteroids are not life-saving and do not have an immediate effect on the symptoms of anaphylaxis but may help reduce or prevent a biphasic \"late phase\" reaction .\n\nThe aim of this study is to compare the efficacy of oral glucocorticoids in prevention of the second phase or biphasic reaction of anaphylaxis, as compared to placebo in children, presenting to the pediatric emergency department (PEC Al-Sadd) with mild to moderate anaphylaxis (Prospective Study).\n\nPatients will be randomized to either one of the two treatment:\n\nTreatment 1: Dexamethasone 0.6mg\u002Fkg oral. Treatment 2 : Placebo All patients will be urgently treated for anaphylaxis according to guideline protocol. Enrolled patients will be given one of the study medications orally, and he \u002Fshe will observe in the observation room with cardiac monitor and close monitoring by nurse.\n\nThe treating physician will discharge patient when he\u002Fshe looks well, breathing comfortably, has oxygen saturation \\>94%, stable blood pressure and no gastrointestinal or neurological manifestation.\n\nDischarge patients will be sent home on anti-histamine (cetirizine) for 5days. All patients will be followed up for one week post discharge by a phone call asking about the general condition, relapse of symptoms, or need for readmission.",[77],"Anaphylaxis",[79],"Mild -Moderate Anaphylaxis","2024-08-13",{"date":82,"type":83},"2024-08-14","ACTUAL",{"date":85,"type":83},"2018-04-15",{"date":87,"type":71},"2024-12",{"name":5,"class":6},1]