Different Levels of BiPAP
This study is focused on improving breathing support for premature babies who need help from a machine called BiPAP. BiPAP gives two levels of air pressure to help babies breathe. Researchers want to find the best upper pressure setting on the BiPAP machine to reduce how hard a baby has to work to breathe. They will measure this effort using a tiny tube placed gently into the baby's stomach. Each baby will try three different upper pressure settings, each for 20 minutes, with breaks in between. The study aims to make this breathing support as effective and comfortable as possible for these tiny patients, especially as there are no clear guidelines for using BiPAP in the UK yet.
At a glance
What is this study about?
When babies are born very early, their lungs might not be fully developed, and they can struggle to breathe on their own. Sometimes, they need a special machine to help them. One such machine is called BiPAP. It's designed to give gentle puffs of air to help the baby's lungs work better, providing two different levels of support.
This study is trying to figure out the very best way to set up the BiPAP machine for these fragile babies. Think of it like adjusting the settings on a car to make it run most smoothly. Researchers want to find the specific upper pressure setting that makes it easiest for the baby to breathe, so they don't have to work as hard. This is important because if a baby is struggling to breathe, it uses up a lot of their energy.
To find this out, they will carefully measure how much effort babies are putting into breathing. They'll do this by placing a very thin, soft tube (like a feeding tube) gently through the baby's mouth and into their stomach. This tube has tiny sensors that can measure the baby's breathing effort. Each baby in the study will try out three different upper pressure settings on the BiPAP machine, each for 20 minutes, with a break on a standard setting in between. The goal is to make sure that when babies need breathing support, it's the best and most comfortable support we can give them.
Key takeaways
- The study aims to find the best BiPAP breathing machine settings for premature babies.
- It helps babies with under-developed lungs by making their breathing easier.
- Researchers will gently measure the baby's breathing effort using a thin tube and skin sensors.
- Each baby will try three different machine settings for short periods.
- The goal is to improve breathing support for current and future premature babies.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is looking for premature babies who were born before 34 weeks of pregnancy at King's College Hospital. They need to be receiving breathing support for the first time, after having a breathing tube removed, or still needing support after seven days.
The baby also needs to be between 2 days and 2 months old when they join the study.
Babies unfortunately can't join if they have any serious breathing problems they were born with, have a confirmed serious infection in their blood, have had recent stomach or bowel surgery within the last week, or if their parents don't 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.
- Was your baby born prematurely (before 34 weeks)?
- Is your baby currently at King's College Hospital needing breathing support?
- Is your baby between 2 days and 2 months old?
- Does your baby NOT have any serious lung problems they were born with?
- Has your baby NOT had recent stomach surgery (in the last 7 days)?
- Are you able to speak English?
What does participation involve?
If your baby takes part in this study, they will receive their usual care, but for a short period, the researchers will try out different settings on their BiPAP breathing machine. Your baby will be on three different upper pressure settings for 20 minutes each. In between these different settings, they will return to the standard BiPAP setting for 20 minutes. During this time, they will have a small, soft tube inserted through their mouth and into their stomach to measure their breathing effort. This tube is similar in size to a feeding tube. There will also be some sticky pads placed on their skin to measure muscle activity related to breathing. The total time for the measurements will be about an hour and a half to two hours. After the study, your baby will continue to receive the breathing support that seems to make them work least hard.
Potential risks and benefits
Locations (1)
- King's College HospitalVerified postcodeLondon, United Kingdom· Recruiting
Common questions
What is BiPAP?
BiPAP is a machine that helps babies breathe by giving them two different levels of gentle air pressure. It's a non-invasive support, meaning no breathing tube is placed down their windpipe.
Why are you doing this study?
We want to find the best possible settings on the BiPAP machine to make breathing easier for premature babies, as there are no clear guidelines yet for its use in the UK.
How will you know if the new settings are better?
We will measure how much effort the baby is making to breathe using a very small, soft tube placed into their stomach, as well as sensors on their skin.
Will my baby be safe during the study?
Yes, your baby's health is our top priority. All procedures are done by experienced medical staff, and your baby will be closely monitored throughout the study.
How long will the study measurements take?
The actual measurement part of the study, where we try different settings, will last about an hour and a half to two hours in total.
How to find out more
Oishi Sikdar
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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