Home Initiation of Noninvasive Positive Pressure Ventilation in Children With Medical Complexity
Many children with complex medical needs struggle with breathing during sleep and need a breathing machine called NiPPV. Usually, this machine is first set up for them during a one-night stay in a hospital sleep lab. However, this can be hard on children and their families due to the unfamiliar environment and disruption to their routine. This study is exploring a new way of doing things: starting the NiPPV machine at home. Children aged 5-17 who are set to begin using NiPPV will be randomly chosen to either start at home or in the hospital sleep lab. The researchers want to check how practical and safe it is to start NiPPV at home. This could eventually make it much easier for families to manage their child's breathing support.
At a glance
What is this study about?
Many children with complex medical needs often have problems breathing properly when they sleep. To help with this, doctors sometimes recommend a special breathing machine called noninvasive positive pressure ventilation, or NiPPV. This machine helps them breathe more easily and can improve their quality of life.
Traditionally, before a child starts using NiPPV regularly, they spend a night in a hospital sleep laboratory. During this stay, doctors adjust the machine to find the best settings for that child. However, we know that staying overnight in a hospital can be difficult for these children and their families. It takes them away from their usual comfortable home environment, and it can be stressful to bring all their necessary items and keep their routine going.
This study aims to find out if it's possible and safe for children to start using their NiPPV machine at home instead of in the hospital. Children aged between 5 and 17 who are about to start NiPPV will be randomly assigned, like flipping a coin, to one of two groups: either they'll start their NiPPV at home, or they'll follow the usual route of starting it in the hospital sleep lab. The researchers will then carefully watch both groups to see how well the home setup works and if it's just as safe as starting in the hospital. The goal is to make it simpler and less stressful for families to begin this important treatment.
Key takeaways
- Looks at starting breathing support at home for children.
- Compares home initiation to standard hospital initiation of NiPPV.
- Aims for a less stressful start to breathing therapy.
- Focuses on safety and practicality of home-based care.
- Designed for children aged 5-17 with complex medical needs.
Who may be eligible?
To join this study, children need to be between 5 and 17 years old and be about to start using a NiPPV breathing machine for the first time. They also need to have tried the machine while awake and found it acceptable.
However, some children won't be able to take part. This includes those with certain heart problems that could make starting NiPPV risky, or if their doctor thinks there's a high chance of other complications, like a collapsed lung. Children with very severe breathing issues at night or those already in another study that might affect how well they use their NiPPV machine will also not be able to participate. Lastly, the child or their main caregiver needs to be able to speak English.
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 5 and 17?
- Is your child about to start using a NiPPV breathing machine for the first time?
- Has your child tried the NiPPV machine while awake and felt fine with it?
- Does your child not have severe heart conditions that would make this new breathing treatment risky?
- Are you, or the main caregiver, able to speak English?
What does participation involve?
If your child joins the study, they will either start their NiPPV machine at home or in a hospital sleep lab, decided randomly. The study will monitor their progress and safety during this initial period. There will be assessments to check how well the machine is working and how your child is getting on. The specific number of visits or assessments will depend on which group your child is in and how they respond, but the focus will be on ensuring the machine is set correctly and safely. You would be expected to follow the guidance given by the study team regarding the use of the NiPPV machine and any monitoring required.
Potential risks and benefits
Locations (1)
- The Hospital for Sick ChildrenVerified postcodeToronto, Canada· Recruiting
Common questions
What is NiPPV?
NiPPV is a special breathing machine that helps children breathe better, especially at night, by gently pushing air into their lungs.
Why is it usually started in hospital?
It's usually started in a hospital sleep lab so doctors can carefully adjust the machine to find the perfect settings for each child while monitoring them closely.
What's the main idea of this study?
The study wants to see if it's safe and practical for children to start using their NiPPV machine at home instead of having to go to the hospital.
How will my child be chosen for home or hospital start?
It will be decided randomly, like a coin toss, which group your child will be in – either starting at home or in the hospital sleep lab.
Who is running this study?
This study is being run by researchers to help improve how children needing breathing support are cared for.
How to find out more
Reshma Amin, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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