[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619530":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":43,"responsibleParty":73,"collaborators":76,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":26,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":115,"whyStopped":26,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"The Hospital for Sick Children","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","Dexamethasone 0.3 mg\u002Fkg (max dose 12 mg) IV after randomization, and a second dose 24 hours (+\u002F-8 hours) after the first dose",[13],"Drug: Dexamethasone 0.3mg\u002Fkg",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Sodium Chloride 0.9% IV after randomization and second dose 24 hours (+\u002F- 8 hours) after the first dose",[19],"Drug: Placebo Control",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Dexamethasone 0.3mg\u002Fkg","SANDOZ-DEXAMETHASONE SODIUM PHOSPHATE INJ USP 4MG\u002FML (5 mL vial) (DIN# 00664227) or any brand available commercially in the Canadian market.\n\nDexamethasone 0.3 mg\u002Fkg (max dose 12 mg) will be given by IV after randomization. The second dose will be given 24 hours (+\u002F-8 hours) after the first dose. The most recent weight recorded in the patient's chart will be used for the dose calculation.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo Control","Sodium Chloride 0.9% Injection USP Placebo Baxter brand (or any commercially available in the Canadian market) given by IV, first dose administered after randomization and second dose 24 hours (+\u002F- 8 hours) after the first.",[15],[32],{"name":33,"affiliation":5,"role":34},"Peter J Gill, MD, DPhil","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","416-813-7654","peter.gill@sickkids.ca",{"name":41,"role":37,"phone":26,"phoneExt":26,"email":42},"Anmol Samra, MPH, BSc","anmol.samra@sickkids.ca",[44,59],{"facility":5,"status":26,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Toronto","Ontario","M5G 1X8","Canada","CA",{"type":51,"coordinates":52},"Point",[53,54],-79.39864,43.70643,{"lat":54,"lon":53},[57],{"name":58,"role":37,"phone":38,"phoneExt":26,"email":39},"Peter J Gill, MD, DPhil, M.Sc., FRCPC",{"facility":60,"status":26,"city":61,"state":26,"zip":62,"country":48,"countryCode":49,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Stollery Children's Hospital","Edmonton","T6G 2B7",{"type":51,"coordinates":64},[65,66],-113.46871,53.55014,{"lat":66,"lon":65},[69],{"name":70,"role":37,"phone":71,"phoneExt":26,"email":72},"Jessica Foulds, MD, FRCPC","780-248-5510","jwylie@ualberta.ca",{"type":34,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Peter Gill","Staff Paediatrician and Senior Scientist",[77],{"name":78,"class":79},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV","100619530","dexamethasone-vs-placebo-in-children-and-youth-hospitalized-for-orbital-cellulitis-100619530",false,"NCT07345819","Dexamethasone vs. Placebo in Children and Youth Hospitalized for Orbital Cellulitis","Dexamethasone vs. Placebo in Children and Youth Hospitalized for Orbital Cellulitis: the VISION Pilot Randomized Clinical Trial","VISION","Inclusion Criteria:\n\n1. Age 2.00 months -17.99 years (prior to 18th birthday)\n2. Confirmed or suspected diagnosis of orbital cellulitis as determined by the attending physician, medical team, and\u002For delegate's clinical judgement, based on one or more features of orbital cellulitis (i.e., ophthalmoplegia, pain and\u002For limitation with extraocular movements, chemosis, blurred vision, eye swollen shut, and\u002For proptosis).\n3. Scheduled to be admitted or admitted to hospital for less than 36 hours.\n4. Informed consent provided in accordance with institutional policies\n\nExclusion Criteria:\n\n1. Transferred directly from outside hospital inpatient setting to a participating hospital site's inpatient setting with over 36 hours having passed since admission to outside hospital. If within 36 hours, patient is eligible.\n2. Treatment with IV or PO systemic corticosteroids within 1 week of presentation\n3. Recent hospital admission for orbital cellulitis within 1 week of presentation\n4. Current systemic fungal infection\n5. Contraindication for dexamethasone or components of dexamethasone IV formulation\n6. Clinically relevant varicella exposure in the previous 21 days\n7. Previous enrollment in this study\n8. No telephone\u002Fmobile\u002Femail\n9. Poor mastery of English, or medical interpreter not available for languages other than English","ALL","2 Months","17 Years",{"count":92,"type":93},30,"ESTIMATED","INTERVENTIONAL",[96],"NA","The goal of this pilot randomized controlled trial is to understand whether we can successfully conduct a larger definitive clinical trial in the future. The current pilot study will test various aspects of the larger trial and help us improve its design if needed. The investigators are mainly interested in knowing whether they can (1) recruit enough patients, (2) administer the intervention, and (3) collect all the data needed from patients. The definitive randomized controlled trial will assess if dexamethasone is superior to placebo for treating children and youth hospitalized with orbital cellulitis.",[99],"Orbital Cellulitis",[101,102,103,104,105,106,107,108,109,110,111,112,113,114],"orbital cellulitis","pilot trial","pilot RCT","preseptal cellulitis","periorbital cellulitis","dexamethasone","corticosteroid","inpatient","RCT","randomized controlled trial","pediatric","paediatric","children","youth","NOT_YET_RECRUITING","2026-01-16",{"date":118,"type":119},"2026-01-21","ACTUAL",{"date":121,"type":93},"2026-04-01",{"date":123,"type":93},"2027-12-31",{"name":5,"class":6},2]