RecruitingNAINTERVENTIONAL

Optimising Ventilation in Preterms With Closed-loop Oxygen Control

Premature babies often need help with their breathing using a machine. While life-saving, these machines can sometimes cause problems for a baby's lungs and other organs. This study is testing a new computer system designed to automatically control the oxygen given to premature babies on breathing machines. This system constantly checks oxygen levels and adjusts the oxygen supply to keep it within a safe range. Researchers hope this automated system might help babies come off breathing machines sooner and reduce potential complications. The study will compare this system to the usual way nurses and doctors manually adjust oxygen levels.

At a glance

Status

Recruiting

Phase

Sponsor

King's College Hospital NHS Trust

Enrolment target

Start

05 Sep 2021

Estimated completion

01 Mar 2025

Infant, Premature, Diseases Airway Morbidity Mechanical Ventilation Complication

What is this study about?

Many premature babies are born with underdeveloped lungs and need help with their breathing, often using a machine called a ventilator. While these machines are vital for keeping babies alive, using them for a long time can sometimes lead to complications for a baby's lungs and other parts of their body. Additionally, giving too much oxygen can also cause problems, particularly for a baby's eyes. It's really important to carefully monitor and adjust the amount of oxygen a baby receives.

Currently, oxygen levels are usually adjusted by nurses and doctors. However, there's a new computer-based system, sometimes called 'closed-loop automated oxygen control,' which is built into the breathing machine. This system automatically adjusts the oxygen levels based on the baby's needs. We know that this automated system is good at keeping oxygen levels within a desired range, and it might even reduce the oxygen faster when needed compared to manual adjustments. This could mean babies wouldn't need to be on the breathing machine for as long.

This study aims to find out if using this automated system actually helps premature babies spend less time on breathing machines. By comparing babies who receive oxygen adjustments from the automated system with those who have their oxygen adjusted manually, we hope to understand if this new technology can reduce the time babies are on ventilators and, in turn, lower the risk of associated complications. This could be a really important step in improving care for our most vulnerable babies.

Key takeaways

This study investigates a new computer system for oxygen control in premature babies on breathing machines.
It aims to see if this automated system can reduce the time babies need the breathing machine.
Your baby would be randomly assigned to either automated or manual oxygen control.
All babies receive standard medical care, and doctors can always intervene if needed.
Participation is voluntary, and you can withdraw your baby at any time without impacting their care.

Who may be eligible?

This study is particularly for very premature babies. To be considered, babies must be born before 31 weeks of pregnancy and need help with their breathing using a machine. They must also be admitted to King's Neonatal Intensive Care Unit (NICU) within the first 48 hours after birth.

Babies would not be able to participate if they were born after 31 weeks of pregnancy or at full term. Also, if a baby has any significant birth defects, they would not be included in this study.

Before any baby can take part, we would need to get permission from their parents or legal guardians. The baby's attending doctor would also need to agree for them to be part of the study.

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 born before 31 weeks of pregnancy?
Does my baby need a breathing machine?
Is my baby admitted to King's NICU within 48 hours of birth?
Does my baby have any major birth defects?

Answer every question to see your result.

What does participation involve?

If your baby is eligible and you agree for them to take part, they would be enrolled within 48 hours of starting on the breathing machine. The study would last until your baby is well enough to come off the breathing machine completely. Your baby would be randomly assigned to one of two groups, like flipping a coin. One group would receive oxygen adjustments through the automated computer system, while the other group would have their oxygen adjusted manually by the clinical team, which is the standard practice.

Regardless of the group, your baby will receive all standard care from the medical team, and their breathing machine settings will be manually adjusted as needed. For the group using the automated system, the new software will automatically adjust the oxygen percentage based on your baby's oxygen levels. However, the medical team can still make manual adjustments at any time if they believe it's best for your baby. We will also collect some basic information about your baby's health to see if anything else might affect how long they need the breathing machine.

Potential risks and benefits

The potential benefits of this study include helping us understand if automated oxygen control can reduce the time premature babies spend on breathing machines, potentially leading to fewer complications. There are no known additional risks to your baby beyond those typically associated with being a very premature infant requiring mechanical ventilation. The automated system is designed to keep oxygen within safe targets, similar to manual control, and the medical team can always intervene. Your baby will receive the best medical care regardless of whether they are in the automated or manual oxygen control group. You are free to withdraw your baby from the study 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.

King's College Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is a 'breathing machine'?

A breathing machine, also called a ventilator, is a medical device that helps premature babies breathe when their lungs are not yet strong enough to do it on their own.

What is 'closed-loop automated oxygen control'?

It's a computer system built into the breathing machine that automatically adjusts the amount of oxygen a baby receives, based on their oxygen levels, without needing frequent manual changes.

Will my baby's care be different if they are in the study?

Your baby will receive the same high standard of care. The only difference is whether their oxygen adjustments are handled automatically by a computer system or manually by the medical team. The medical team can always override the system if needed.

Can I take my baby out of the study?

Yes, you can withdraw your baby from the study at any time, for any reason. This will not affect the medical care your baby receives in any way.

What if my baby needs to go back on the breathing machine?

If your baby needs to go back on the breathing machine within 48 hours of coming off it, and is still under 28 days old, they will continue in the same study group they were originally assigned to.

How to find out more

Ourania Kaltsogianni, MSc

ourania.kaltsogianni@nhs.net (+44)02032999000 Official trial record

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