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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
This is a double-blinded, placebo-controlled, internal pilot randomized controlled trial, with two parallel groups with a 1:1 allocation ratio, at The Hospital for Sick Children (Toronto, ON) and Stollery Children's Hospital (Edmonton, AB).The purpose of the study is to determine the feasibility of a definitive randomized controlled trial, which will determine whether IV dexamethasone 0.3 mg/kg after randomization and 24 hours later (2 doses total) is superior to placebo for children and youth hospitalized with orbital cellulitis.
Children and youth (n=30) hospitalized with orbital cellulitis will be randomized to receive IV dexamethasone 0.3 mg/kg (first dose after randomization, second dose 24 hours later) or placebo. The primary feasibility outcome of this pilot trial is recruitment rate. Secondary feasibility outcomes include (a) intervention fidelity, (b) completion of definitive trial primary, and (c) completion of definitive trial secondary outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Dexamethasone 0.3 mg/kg (max dose 12 mg) IV after randomization, and a second dose 24 hours (+/-8 hours) after the first dose |
|
| Placebo | Placebo Comparator | Sodium Chloride 0.9% IV after randomization and second dose 24 hours (+/- 8 hours) after the first dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone 0.3mg/kg | Drug | SANDOZ-DEXAMETHASONE SODIUM PHOSPHATE INJ USP 4MG/ML (5 mL vial) (DIN# 00664227) or any brand available commercially in the Canadian market. Dexamethasone 0.3 mg/kg (max dose 12 mg) will be given by IV after randomization. The second dose will be given 24 hours (+/-8 hours) after the first dose. The most recent weight recorded in the patient's chart will be used for the dose calculation. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Recruitment rate is measured as the number of patients agreeing to participate in the trial and are randomized, divided by the number of patients screened as eligible at 18 months after initiation of the trial recruitment (per site). | From start of recruitment to end of recruitment (anticipated 18 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention fidelity | Intervention fidelity is the proportion of randomized patients who receive the intervention or placebo at the correct dose and time, without receiving any off-protocol corticosteroids, at each site. It will be assessed 96 hours after hospital admission, defined as the patient receiving two doses of 0.3 mg/kg dexamethasone or placebo (first dose after randomization; second dose at 24 +/- 8hrs after first dose). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter J Gill, MD, DPhil | Contact | 416-813-7654 | peter.gill@sickkids.ca | |
| Anmol Samra, MPH, BSc | Contact | anmol.samra@sickkids.ca |
| Name | Affiliation | Role |
|---|---|---|
| Peter J Gill, MD, DPhil | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41381246 | Background | Gonsalves CL, Borkhoff C, Mahant S, Drouin O, Pound C, Quet J, Wahi G, Bayliss A, Vomiero G, Foulds JL, Kanani R, Sakran M, Sehgal A, Pullenayegum E, Widjaja E, Reginald A, Wolter NE, Parkin PC, Gill PJ; Periorbital and Orbital Cellulitis (POC) Multicentre Study Group and Canadian Paediatric Inpatient Research Network (PIRN). Association of systemic corticosteroids and clinical outcomes in children hospitalised with severe orbital infections. BMJ Paediatr Open. 2025 Dec 11;9(1):e004161. doi: 10.1136/bmjpo-2025-004161. | |
| 33908631 |
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| ID | Term |
|---|---|
| D054517 | Orbital Cellulitis |
| ID | Term |
|---|---|
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D002481 | Cellulitis |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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|
| Placebo Control | Drug | 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 (+/- 8 hours) after the first. |
|
| 96 hours after the patient is admitted to hospital. |
| Completion of definitive trial primary and secondary outcomes | Completion of definitive trial primary and secondary outcomes is defined as the proportion of randomized patients with complete data for the definitive trial primary outcome (length of hospital stay) and the definitive trial secondary outcomes, at each site. The definitive trial secondary outcomes include: Surgical intervention, clinical outcomes (e.g. vision, pain, swelling), healthcare use (ICU admission, revisits to medical care and hospital), perceived stress experienced by parents, and adverse events. | Three months after the patient is discharged from hospital. |
| Stollery Children's Hospital | Edmonton | T6G 2B7 | Canada |
|
| Background |
| Kornelsen E, Mahant S, Parkin P, Ren LY, Reginald YA, Shah SS, Gill PJ. Corticosteroids for periorbital and orbital cellulitis. Cochrane Database Syst Rev. 2021 Apr 28;4(4):CD013535. doi: 10.1002/14651858.CD013535.pub2. |
| 34877598 | Background | Gill PJ, Mahant S, Hall M, Parkin PC, Shah SS, Wolter NE, Mestre M, Markham JL. Association Between Corticosteroids and Outcomes in Children Hospitalized With Orbital Cellulitis. Hosp Pediatr. 2022 Jan 1;12(1):70-89. doi: 10.1542/hpeds.2021-005910. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |