Orbital CellulitisVISIONNCT07345819
Dexamethasone vs. Placebo in Children and Youth Hospitalized for Orbital Cellulitis
A study testing Dexamethasone 0.3mg/kg in people with Orbital Cellulitis, run by The Hospital for Sick Children at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 17 years
- Conditions the study is for
- Orbital Cellulitis
- What is being tested?
- Dexamethasone 0.3mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Apr 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 2.00 months -17.99 years (prior to 18th birthday)
- 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).
- Scheduled to be admitted or admitted to hospital for less than 36 hours.
- Informed consent provided in accordance with institutional policies
Who cannot join
- 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.
- Treatment with IV or PO systemic corticosteroids within 1 week of presentation
- Recent hospital admission for orbital cellulitis within 1 week of presentation
- Current systemic fungal infection
- Contraindication for dexamethasone or components of dexamethasone IV formulation
- Clinically relevant varicella exposure in the previous 21 days
Show all 9Show fewer
- Previous enrollment in this study
- No telephone/mobile/email
- Poor mastery of English, or medical interpreter not available for languages other than English
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anmol Samra, MPH, BSc contact
Canada2 sites
Stollery Children's Hospital
Edmonton, T6G 2B7
Jessica Foulds, MD, FRCPC, 780-248-5510, jwylie@ualberta.ca
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Peter J Gill, MD, DPhil, M.Sc., FRCPC, 416-813-7654, peter.gill@sickkids.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Orbital Cellulitis
- Being tested
- Dexamethasone 0.3mg/kg, Placebo Control
- Keywords
- orbital cellulitis, pilot trial, pilot RCT, preseptal cellulitis, periorbital cellulitis, dexamethasone, corticosteroid, inpatient, RCT, randomized controlled trial, pediatric, paediatric, children, youth
- Medical subject headings
- Orbital Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 0.3mg/kgDrug
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 ControlDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Dexamethasone 0.3mg/kg |
| Placebo | Placebo comparator | Sodium Chloride 0.9% IV after randomization and second dose 24 hours (+/- 8 hours) after the first dose Receives: Drug: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From start of recruitment to end of recruitment (anticipated 18 months).
Secondary outcomes (2)
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).
Measured: 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.
Measured: Three months after the patient is discharged from hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Orbital CellulitisStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Peter Gill, The Hospital for Sick Children
- Investigators
- Peter J Gill, MD, DPhil, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345819
- Sponsor's protocol ID
- 3800
- Acronym
- VISION
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41381246Kornelsen 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.
PubMed 33908631Gill 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.
PubMed 34877598
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone vs. Placebo in Children and Youth Hospitalized for Orbital Cellulitis: the VISION Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07345819
- Acronym / sponsor ID
- VISION / 3800
- Conditions
- Orbital Cellulitis
- Keywords
- orbital cellulitis, pilot trial, pilot RCT, preseptal cellulitis, periorbital cellulitis, dexamethasone, corticosteroid, inpatient
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Dexamethasone 0.3mg/kgDexamethasone 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 | Drug: Placebo ControlSodium Chloride 0.9% IV after randomization and second dose 24 hours (+/- 8 hours) after the first dose |
Who may qualify
- Ages
- 2 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 2.00 months -17.99 years (prior to 18th birthday)
- 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).
- Scheduled to be admitted or admitted to hospital for less than 36 hours.
- Informed consent provided in accordance with institutional policies
Key exclusion criteria (9 listed)
- 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.
- Treatment with IV or PO systemic corticosteroids within 1 week of presentation
- Recent hospital admission for orbital cellulitis within 1 week of presentation
- Current systemic fungal infection
- Contraindication for dexamethasone or components of dexamethasone IV formulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone 0.3mg/kgSANDOZ-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 | Intervention |
| Placebo ControlSodium 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. | Drug | Placebo |
Primary outcome
Recruitment rate
Time frame: From start of recruitment to end of recruitment (anticipated 18 months).
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).
2 secondary outcomes
Intervention fidelity
Time frame: 96 hours after the patient is admitted to hospital.
Completion of definitive trial primary and secondary outcomes
Time frame: Three months after the patient is discharged from hospital.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 41381246Gonsalves 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.
- Background: PubMed 33908631Kornelsen 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.
- Background: PubMed 34877598Gill 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anmol Samra, MPH, BSc contact
Peter J Gill, MD, DPhil principal investigator
The Hospital for Sick Children
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone 0.3mg/kg in people with Orbital Cellulitis, run by The Hospital for Sick Children at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter J Gill, MD, DPhil (416-813-7654, peter.gill@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: From start of recruitment to end of recruitment (anticipated 18 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07345819, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.