Not yet recruitingNAINTERVENTIONAL

Automated Oxygen Control in Preterms on Non-invasive Ventilation

This study is investigating a new, automated way to give oxygen to premature babies who need breathing support. It's for infants born before 34 weeks of pregnancy who are in the neonatal intensive care unit (NICU) at King's College Hospital. Currently, doctors and nurses manually adjust oxygen levels. This trial will compare that standard method with a computer-controlled system that aims to keep oxygen levels more stable. The hope is that the automated system will help babies spend less time on extra oxygen, avoid problems like very low or very high oxygen levels, and potentially reduce serious lung conditions like bronchopulmonary dysplasia (BPD). This could help babies recover quicker and spend less time in the NICU.

At a glance

Status

Not yet recruiting

Phase

Sponsor

King's College Hospital NHS Trust

Enrolment target

Start

01 Jun 2026

Estimated completion

01 Sep 2027

Infant Premature Airway Morbidity

What is this study about?

This research study is about finding better ways to give oxygen to premature babies. When babies are born early (before 34 weeks of pregnancy), their lungs aren't fully developed, and they often need help with breathing and extra oxygen. This extra oxygen is vital, but getting the amount just right is tricky. Too much oxygen can sometimes cause harm, like increasing the risk of lung problems or affecting their eyes. Too little oxygen can also be dangerous for their developing bodies.

Currently, doctors and nurses constantly check and manually adjust the oxygen levels for these babies. This study wants to see if an automated system, like a computer looking after the oxygen, could do a better job. This ‘closed-loop automated oxygen control’ system would continuously monitor the baby’s oxygen levels and make small, immediate adjustments as needed, without a person having to do it every time. Previous research has suggested that these automated systems might be more effective at keeping oxygen levels just right.

The main goals of this study are to see if this automated system can help babies spend less time on extra oxygen, keep their oxygen levels more consistently within the healthy range (avoiding both too low and too high levels), and reduce the need for nurses to make many manual adjustments. Ultimately, the researchers hope that this could lead to fewer complications, such as a serious lung condition called bronchopulmonary dysplasia (BPD), and allow babies to recover and go home sooner. This research is important because it could lead to improved care for very vulnerable premature infants.

Key takeaways

This study compares automated vs. manual oxygen delivery for premature babies.
It's for babies born before 34 weeks needing breathing support in intensive care.
The goal is to improve oxygen stability, reduce complications, and shorten hospital stays.
Participation means random assignment to either the automated or manual oxygen group.
All care will be closely monitored, with no extra visits just for the study.

Who may be eligible?

This study is looking for very premature babies who are currently receiving breathing support in the neonatal intensive care unit (NICU).

To be considered for the study, babies must have been born before reaching 34 weeks of pregnancy. They also need to be receiving 'non-invasive respiratory support,' which means they're getting help with their breathing without a tube placed directly into their windpipe. This includes methods like CPAP (continuous positive airway pressure), NIPPV (non-invasive positive pressure ventilation), or high-flow nasal cannula (special tubes in the nose delivering warm, moist air).

However, some babies cannot take part. This includes infants who have certain serious heart problems they were born with (called congenital cyanotic heart disease) or other known major health conditions present at birth.

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 before 34 weeks of pregnancy?
Is your baby currently receiving breathing help like nasal CPAP or high-flow oxygen?
Does your baby *not* have a serious heart condition from birth?
Does your baby *not* have other major health problems they were born with?

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 will be randomly assigned to one of two groups, like flipping a coin. One group will receive oxygen through the new automated system, while the other group will receive oxygen with the usual manual adjustments by the medical team. You won't get to choose which group your baby is in.

The study will closely monitor your baby's oxygen levels and how long they need breathing support. Doctors and nurses will also track if your baby experiences very low or very high oxygen levels, how many times oxygen settings need to be changed, and their overall progress, including how long they stay in the NICU. The study team will follow your baby until they reach about 36 weeks since conception (their 'postmenstrual age') to check for any long-term lung issues like BPD. All these assessments will be part of the normal care your baby receives in the NICU, so there won't be extra visits or special medications just for the study.

Potential risks and benefits

Participating in this study might offer a potential benefit for your baby, as the automated oxygen system could lead to more stable oxygen levels and potentially reduce risks of certain complications. However, there's no guarantee, and your baby will receive excellent care regardless of which group they are in. The risks involved are considered minimal, as both methods, automated and manual, aim to keep your baby safe and well by maintaining healthy oxygen levels. You have the right to withdraw your baby from the study at any time, for any reason, 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

Common questions

What is 'non-invasive respiratory support'?

It means your baby is getting breathing help without a tube in their windpipe, using methods like small masks or prongs in their nose.

What does 'automated oxygen control' mean?

It's a computer system that continuously monitors your baby's oxygen and automatically adjusts the amount they receive to keep it at the right level.

Will my baby get different medical care if we join?

All babies in the study will receive excellent care. The only difference is how their oxygen is controlled – either by the automated system or by manual adjustments from the nurses and doctors.

What is BPD?

BPD stands for Bronchopulmonary Dysplasia. It's a type of chronic lung condition that can affect premature babies, making it harder for them to breathe.

Can I change my mind after joining the study?

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

How to find out more

Ourania Kaltsogianni, MD (Res)

ourania.kaltsogianni@nhs.net +44020 3299 9000 Official trial record

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