Dexamethasone vs. Placebo in Children and Youth Hospitalized for Orbital Cellulitis (VISION)

Dexamethasone vs. Placebo in Children and Youth Hospitalized for Orbital Cellulitis: the VISION Pilot Randomized Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Orbital Cellulitis
• Intervention / Treatment: Drug: Dexamethasone 0.3mg/kg; Drug: Placebo Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anmol Samra, MPH, BSc; Email: anmol.samra@sickkids.ca
• Study Contact Backup: Name: Peter J Gill, MD, DPhil; Phone Number: 416-813-7654; Email: peter.gill@sickkids.ca

Study Locations

• Canada
  • Edmonton, Canada, T6G 2B7
    • Stollery Children's Hospital
    • Contact: Jessica Foulds, MD, FRCPC; Phone Number: 780-248-5510; Email: jwylie@ualberta.ca
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children
      • Contact: Peter J Gill, MD, DPhil, M.Sc., FRCPC; Phone Number: 416-813-7654; Email: peter.gill@sickkids.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 2.00 months -17.99 years (prior to 18th birthday)
2. Confirmed or suspected diagnosis of orbital cellulitis as determined by the attending physician, medical team, and/or delegate's clinical judgement, based on one or more features of orbital cellulitis (i.e., ophthalmoplegia, pain and/or limitation with extraocular movements, chemosis, blurred vision, eye swollen shut, and/or proptosis).
3. Scheduled to be admitted or admitted to hospital for less than 36 hours.
4. Informed consent provided in accordance with institutional policies

Exclusion Criteria:

1. 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.
2. Treatment with IV or PO systemic corticosteroids within 1 week of presentation
3. Recent hospital admission for orbital cellulitis within 1 week of presentation
4. Current systemic fungal infection
5. Contraindication for dexamethasone or components of dexamethasone IV formulation
6. Clinically relevant varicella exposure in the previous 21 days
7. Previous enrollment in this study
8. No telephone/mobile/email
9. Poor mastery of English, or medical interpreter not available for languages other than English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Dexamethasone 0.3 mg/kg (max dose 12 mg) IV after randomization, and a second dose 24 hours (+/-8 hours) after the first dose	Drug: Dexamethasone 0.3mg/kg; 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.
Placebo Comparator: Placebo; Sodium Chloride 0.9% IV after randomization and second dose 24 hours (+/- 8 hours) after the first dose	Drug: 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 (+/- 8 hours) after the first.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	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).	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.

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Peter J Gill, MD, DPhil, The Hospital for Sick Children

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 16, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; pediatric; children; RCT; corticosteroid; dexamethasone; youth; paediatric; inpatient; pilot trial; pilot RCT; orbital cellulitis; preseptal cellulitis; periorbital cellulitis
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Eye Diseases; Orbital Diseases; Skin and Connective Tissue Diseases; Cellulitis; Orbital Cellulitis; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Dexamethasone
• Other Study ID Numbers: 3800

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No