Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07345819
NA

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

Sponsor: The Hospital for Sick Children

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

2 Months - 17 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-04-01

Completion Date

2027-12-31

Last Updated

2026-01-21

Healthy Volunteers

No

Interventions

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.

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.

Locations (2)

The Hospital for Sick Children

Toronto, Ontario, Canada

Stollery Children's Hospital

Edmonton, Canada