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Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Safe, effective and cost-effective oxygen saturation targets for children and adolescents with respiratory distress: a randomized controlled trial.

This study is for children and teenagers with breathing difficulties caused by conditions like bronchiolitis or chest infections. Researchers want to find the best level of oxygen to give them, called 'oxygen saturation targets'. They are comparing current practices with a special oxygen treatment called 'Conoxia Liquid'. The main goal is to see if different oxygen levels can help children recover quickly, get home sooner, and need fewer hospital visits. They also want to check if this is good for children's overall health, their parents' worries, and if it's a cost-effective treatment.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic use (Phase IV)
Sponsor
Spaarne Gasthuis
Enrolment target
560
Start
27 Jun 2023

What is this study about?

Imagine your child has a cough or a chest infection that makes it hard to breathe. Sometimes, doctors give extra oxygen to help. This study, called a clinical trial, is looking into how much oxygen is just right for children and teenagers with breathing problems. We want to find out if specific oxygen levels, called 'oxygen saturation targets', can help children get better faster and go home sooner.

The study involves conditions like bronchiolitis (a common chest infection in babies), viral wheezing, and other lower chest infections. We're comparing standard oxygen care with a specific type of oxygen treatment called 'Conoxia Liquid'. This is a 'Phase IV' study, which means the treatment is already approved but we're looking at its best use in real-world situations, like how it affects children specifically.

The main thing we want to measure is how long it takes from when a child comes into the hospital until they meet all the requirements to go home. We'll also look at other important things like their total time in hospital, whether they need to go to intensive care, how long they need oxygen, how quickly their symptoms go away, and how long until they can return to school or nursery. We'll also check their quality of life, how worried parents are, and the overall health of the children, while also considering the costs involved.

Key takeaways

  • The study explores the best oxygen levels for children with breathing problems.
  • It aims to help children recover faster and go home sooner.
  • Conditions like bronchiolitis and chest infections are included.
  • Compares standard oxygen care with 'Conoxia Liquid' treatment.
  • Looks at overall health, parent anxiety, and cost-effectiveness.
  • Open to children and teenagers of all ages.

Who may be eligible?

This study is open to children and teenagers of all ages, both boys and girls, who are experiencing breathing difficulties due to certain conditions. These conditions include bronchiolitis, viral wheeze (where a virus makes breathing noisy or difficult), and other infections affecting the lower parts of the lungs, like a chest infection.

The study aims to include a wide range of young people to ensure the results are helpful for many families. There are no specific age limits; it covers everyone from the youngest babies to older teenagers. Doctors will likely assess each child to make sure the study medication and approach are suitable for their specific situation.

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.

  1. Is my child experiencing breathing difficulties?
  2. Does my child have bronchiolitis, viral wheeze, or a lower chest infection?
  3. Is my child currently in hospital with these breathing issues?
  4. Am I happy for my child's medical information to be part of a research study?
Answer every question to see your result.

What does participation involve?

If your child takes part, they will receive either the standard oxygen care or the special 'Conoxia Liquid' oxygen treatment, depending on what the study assigns. Doctors will carefully monitor your child's oxygen levels and overall health. They will keep track of things like how long your child stays in hospital, how much oxygen they need, and how quickly they recover. We will also ask about your child's symptoms and when they return to their normal activities, like going back to school or nursery. There will be follow-up checks after your child is discharged to see if they need any unscheduled healthcare visits. The total duration of participation will depend on how long your child needs hospital care and the follow-up period after discharge.

Potential risks and benefits

Taking part could offer potential benefits as the study aims to find the best way to help children recover faster from breathing difficulties. All medical treatments carry some risks, but your child will be closely monitored by medical staff throughout the study. Remember, participating in a clinical trial is always your choice, and you are free to withdraw your child at any time without affecting their medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Netherlands

Common questions

What is 'oxygen saturation'?

Oxygen saturation is a measure of how much oxygen is in your child's blood. Doctors aim for a 'target' level to help them breathe comfortably.

What is 'bronchiolitis'?

Bronchiolitis is a common chest infection in babies and young children that can make breathing difficult.

Is 'Conoxia Liquid' a new medicine?

Conoxia Liquid is a medicinal oxygen gas that's already approved. This study looks at the best way to use it for children with breathing issues.

Will my child go to intensive care?

The study will track if children need intensive care, but the goal is to find oxygen levels that help them avoid it if possible.

Will this study cost me anything?

No, there will be no cost to you for your child's participation in the study.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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