Dexamethasone vs. Placebo in Children and Youth Hospitalized for Orbital Cellulitis
This study is a small, initial trial for children and young people admitted to hospital with an eye infection called orbital cellulitis. It's like a practice run to see if a bigger study can be successfully carried out in the future. Researchers want to find out if they can enrol enough patients, give them the study medication (dexamethasone or a dummy treatment), and collect all the health information needed. The overall goal of a future, larger study would be to see if dexamethasone is better than a dummy treatment for children and young people with this infection. Currently, this small study is helping improve the design of that future main trial.
At a glance
What is this study about?
Imagine your child has an eye infection that’s serious enough for them to be in hospital. This infection is called orbital cellulitis. It can cause the eye to swell and become painful. Doctors want to find the best ways to treat this condition.
This specific study is a small, initial step, sometimes called a 'pilot' study. Its main purpose isn't to say whether a particular medicine works, but rather to test how well a bigger, more important study could be run later on. Think of it as a dress rehearsal before a main play. Researchers are checking things like whether they can find enough children to join, whether they can give the study medicine as planned, and if they can gather all the important health information from the children.
The medicine being looked at in this research is called dexamethasone. This is a type of steroid. In a future, larger study, doctors would want to compare dexamethasone with a dummy treatment (a ‘placebo’) to see if dexamethasone helps children with orbital cellulitis get better faster or more completely. This pilot study is helping them learn how to do that main study in the best way possible.
Key takeaways
- This is a pilot study, a practice run for larger research.
- It's for children and young people with a serious eye infection called orbital cellulitis.
- The study tests how well a future study on dexamethasone can be done.
- Participants will receive either dexamethasone or a dummy treatment.
- Joining helps improve future treatments for children with this condition.
Who may be eligible?
This study is looking for children and young people between 2 months and just under 18 years old. They must have a confirmed or suspected diagnosis of orbital cellulitis, which is a serious eye infection, and be in hospital for it, or about to be admitted, within the last 36 hours.
There are also some reasons why a child might not be able to join. For example, if they've recently had another hospital stay for orbital cellulitis, or if they've taken certain steroid medications in the last week. Children with a particular type of fungal infection or who have been exposed to chickenpox recently would also not be able to take part. Also, if a child cannot safely take dexamethasone for any reason, they wouldn't be eligible.
Finally, for a child to be part of the study, their parents or guardians must be able to give their agreement following clear information about the study. This usually means being able to communicate with the study team, either in English or with a medical interpreter provided.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is your child aged between 2 months and just under 18 years?
- Does your child have orbital cellulitis and is currently in hospital, or just arrived?
- Has your child NOT had steroid medicines by drip or mouth in the last week?
- Has your child NOT had chickenpox recently (in the last 3 weeks)?
- Are you able to provide consent and communicate with the study team?
What does participation involve?
If your child qualifies and you agree for them to take part, they would be looked after at The Hospital for Sick Children in Toronto or Stollery Children's Hospital in Edmonton. They would be randomly assigned to receive either the study medicine, dexamethasone, or a dummy treatment (placebo). This is done through a process like flipping a coin, so neither you, your child, nor the doctors will know which one they are getting. Both are given as a drip into their vein. They would receive one dose shortly after joining the study and another dose 24 hours later. The study team would then closely monitor your child's health and collect information relevant to their recovery. The exact total duration of participation isn't specified for this pilot, but it would involve their hospital stay and collection of data during that time.
Potential risks and benefits
Locations (2)
- The Hospital for Sick ChildrenVerified postcodeToronto, Canada
- Stollery Children's HospitalVerified postcodeEdmonton, Canada
Common questions
What is orbital cellulitis?
It's a serious infection around the eye that can cause swelling, pain, and difficulty moving the eye. It usually requires hospital treatment.
What is dexamethasone?
Dexamethasone is a type of steroid medication that can reduce swelling and inflammation in the body.
What is a 'pilot study'?
A pilot study is like a small practice run for a bigger study. It helps researchers test their plans and make sure they can run the main study well.
Will my child know if they are getting the study medicine or a dummy treatment?
No, neither you, your child, nor the doctors participating in the study will know. This is called 'double-blinded' and helps ensure the study results are fair.
Can I remove my child from the study if I change my mind?
Yes, you can withdraw your child from the study at any time. This decision will not affect the medical care they receive.
How to find out more
Peter J Gill, MD, DPhil
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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