RecruitingInterventional

Automatic high flow oxygen support for tiny babies during breathing tube placement – a research study

This research is about making a life-saving procedure safer for premature babies. Sometimes, very tiny babies need a breathing tube placed in their windpipe (called intubation). This can be a difficult procedure, and often babies' oxygen levels or heart rates can drop, meaning the procedure has to be stopped. We want to see if using a special type of breathing support, called 'high flow', along with an automatic oxygen control system, works better at keeping oxygen levels stable compared to using 'high flow' breathing support alone. The study will compare these two methods to find the best way to prevent drops in oxygen during intubation, which could lead to a higher success rate for the procedure and fewer problems for the babies.

At a glance

Status

Recruiting

Sponsor

South Tees Hospitals NHS Foundation Trust

Enrolment target

Start

01 Oct 2025

Estimated completion

30 Dec 2026

Preterm intubations

What is this study about?

When tiny premature babies are born, some might need a breathing tube put into their windpipe. This important procedure, called intubation, helps them breathe and is often life-saving. However, it can be quite tricky, especially in very small babies. During the intubation, babies' oxygen levels or heart rates can sometimes fall too low, which can be worrying and might mean the procedure needs to be paused or stopped.

Doctors already use a type of breathing support called 'high flow' therapy, which delivers air and oxygen through small tubes placed in the baby's nose. There's also a newer technology that automatically adjusts the oxygen levels given during this support. We believe that using 'high flow' with this automatic oxygen control might be better at keeping babies' oxygen levels stable during intubation, compared to just using 'high flow' support without the automatic control.

This study aims to compare these two ways of giving breathing support – 'high flow' on its own, versus 'high flow' with automatic oxygen control. By carefully comparing them, we hope to find out which method is more effective at preventing drops in oxygen levels during intubation. The results could help doctors improve how they carry out this vital procedure for premature babies, making it safer and more successful.

Key takeaways

The study aims to make placing breathing tubes in premature babies safer.
It compares two types of breathing support during the procedure: 'high flow' alone versus 'high flow' with automatic oxygen control.
The goal is to see which method best prevents drops in oxygen levels.
Participation involves receiving one of these standard breathing support methods.
There are no extra risks or tests for babies taking part in the study.
Results could improve care for premature babies needing breathing tubes.

Who may be eligible?

This study is looking for very premature babies born before 30 weeks of pregnancy who need a breathing tube to be inserted. The doctors will determine if a baby needs this procedure.

However, some babies might not be able to join the study. This includes babies who have certain health problems with their airways, heart, or lungs (like a collapsed lung), or if they have special conditions that make using 'high flow' breathing support unsuitable. Babies who need a breathing tube during birth, or in an emergency where there isn't time to prepare, also won't be able to participate. Also, babies who have had difficulties with breathing tube insertions before might not be suitable.

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 my baby a tiny premature baby (born before 30 weeks of pregnancy)?
Does my baby need a breathing tube put in for breathing support?
Does my baby have any major problems with their airways, heart, or lungs?
Has my baby had an easy time if a breathing tube was placed before (few attempts)?
Is my baby undergoing this procedure in the neonatal unit, not in the delivery room or an emergency?

Answer every question to see your result.

What does participation involve?

If your baby is eligible for the study, they will be assigned one of two types of breathing support during the procedure to place a breathing tube. This will be decided by chance, like flipping a coin. One group will receive 'high flow' breathing support only, and the other will receive 'high flow' support along with automatic control of oxygen. Both types of support are commonly used in hospitals.

There are no extra visits or special assessments required for this study. The breathing tube procedure and the breathing support provided are part of your baby's standard care. The research team, who are experienced neonatal doctors and nurses, will simply make sure your baby receives the assigned breathing support during the intubation. The study will run from January 2025 to December 2026, and your baby's participation would be for the duration of one intubation procedure.

Potential risks and benefits

One potential benefit of taking part is that both types of breathing support being studied (high flow, with or without automatic oxygen control) are already known to help during intubation. They might lead to the breathing tube being placed successfully on the first try, which could then help your baby avoid needing several attempts, and the potential problems that can come with that. It's important to know that the study itself doesn't add any extra risks or burdens to your baby. Both the 'high flow' and automated oxygen systems are commonly used and safe in neonatal units. You or your baby's medical team always have the right to withdraw from the study at any time without affecting your baby's care.

Locations (2)

James Cook University Hospital
Approximate
Middlesbrough, England
Medway NHS Foundation Trust
City only
Gillingham, England

Common questions

What is 'intubation'?

Intubation is when doctors gently place a breathing tube into a baby's windpipe to help them breathe, especially if they are very ill or premature.

What is 'high flow' breathing support?

'High flow' is a common way to give breathing support to babies through small tubes placed in their nose, delivering air and oxygen.

Will my baby get extra tests because of this study?

No, your baby will not have any extra tests or procedures specifically because of taking part in this study. The care they receive will be part of their normal hospital treatment.

Who is paying for this study?

The study is being funded by a medical equipment company called VAPOTHERM (UK).

Can I decide not to let my baby take part?

Yes, completely. Taking part is entirely your choice, and if you say no, it will not affect the medical care your baby receives in any way.

How to find out more

Prakash Kannan Loganathan

pkannanloganathan@nhs.net +44 1642 854874 Official trial record

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