Not yet recruitingOBSERVATIONAL

Effect of Automated Oxygen Control on Early-childhood Lung Mechanics

This study explores the breathing health of children who were born very prematurely and needed help with oxygen. We know that premature babies can have long-term breathing problems, and oxygen treatment can sometimes add to this risk. This study focuses on a special 'automatic' oxygen control system used when these children were tiny babies. We want to see if using this system helped their lungs develop better and reduced breathing issues as they grew up. Researchers will ask parents to bring their children for a simple lung test and to fill out a questionnaire about their child's breathing. The results will help us understand if this automatic oxygen system can lead to healthier lungs for premature babies in the future.

At a glance

Status

Not yet recruiting

Sponsor

King's College Hospital NHS Trust

Enrolment target

Start

12 Oct 2026

Estimated completion

12 Oct 2027

Prematurity Respiratory Distress Neonatal Oxygen Delivery

What is this study about?

This study is about understanding the breathing health of children who were born very early, before 34 weeks of pregnancy. When babies are born this early, their lungs aren't fully developed, and they often need special machines to help them breathe (called mechanical ventilation) and extra oxygen. While this help is vital, it can sometimes increase their risk of long-term breathing problems as they grow older.

Previously, a study looked at two ways of giving oxygen to these tiny babies: a standard, manual way, and a newer, 'automated' way that adjusts oxygen levels automatically. That study found that the automatic system might help babies need less time on breathing machines and oxygen. Now, this new study wants to find out if using that automatic oxygen system during their time in the neonatal unit (the special care unit for newborns) has a lasting positive effect on their lungs as they become toddlers and young children. We want to see if it helps their lungs work better and if they have fewer breathing problems as they grow up.

Researchers will compare children who received the automatic oxygen control with those who received the standard oxygen care. This information is important because it could lead to better ways of caring for very premature babies, helping them to have healthier lungs throughout their childhood and beyond. The study will take place at King's College Hospital, and children will be invited to attend an outpatient appointment.

Key takeaways

This study looks at how automated oxygen control for premature babies affects their breathing later in life.
It involves one visit to King's College Hospital for a simple breathing test and questionnaire.
The study aims to improve care for future premature babies.
Participation is voluntary, and you can withdraw at any time.
The breathing test is safe and non-invasive.

Who may be eligible?

To be part of this study, children must meet certain conditions. They need to have been born very early, before 34 weeks of pregnancy. They also must have taken part in a previous study at King's College Hospital that compared automatic and manual oxygen control for premature babies.

We are looking for children who are now between 1 and 5 years old and are generally well. They should not be using breathing support machines at home or have a breathing tube (called a tracheostomy). Also, parents or guardians should be able to speak English to understand the study information.

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 child born before 34 weeks of pregnancy?
Did your child take part in the previous King's College Hospital oxygen control study?
Is your child now between 1 and 5 years old?
Does your child not need a home breathing machine or a breathing tube (tracheostomy)?
Are you able to communicate in English?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the research team will first contact you by phone or email. They will send you information about the study and answer any questions you have. If you agree, you'll need to sign a consent form, which means you understand and agree for your child to participate.

Your child will be asked to visit the children's outpatient department at King's College Hospital for one appointment. This appointment will happen when your child is feeling well and hasn't had a chest infection in the last four weeks. During this visit, we will measure your child's height and weight. Your child will also do a simple breathing test called 'forced oscillation'. This involves breathing gently through a mask or mouthpiece for short periods, usually three times, with each test lasting up to 20 seconds. It's not painful or uncomfortable. You will also be asked to complete a questionnaire about your child's breathing and overall health since leaving the hospital as a baby. The whole study is expected to last 12 months in total, but your child's involvement will be just the one visit.

Potential risks and benefits

There are no known direct medical benefits for your child by taking part in this study, but the information we gather could help improve care for other premature babies in the future. The breathing test is very safe, non-invasive, and well-tolerated by children. The main inconvenience is the time it takes for the hospital visit. Remember, participating is entirely voluntary, and you are free to withdraw your child from the study at any time without giving a reason, and it won't affect your child's medical care.

Locations (1)

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

Common questions

What is 'forced oscillation'?

It's a simple, non-invasive breathing test that measures how well your child's lungs are working by gently sending small air waves into their lungs while they breathe normally through a mask or mouthpiece.

How long will the hospital visit take?

The visit will include time for consent, measuring your child, the breathing test, and completing a questionnaire. The breathing test itself is very short, but the overall appointment will likely take a bit longer.

Does my child need to do anything special before the visit?

Your child should be feeling well and not have had a cough or cold, or any other chest infection, in the four weeks before the appointment.

Will we get to know the results for our child?

The study aims to look at group results. You can ask the research team if individual results can be shared, but they may not be directly interpretable without further medical assessment.

What happens to our child's medical information?

Your child's medical information will be kept confidential and used only for this research. Any details that could identify your child will be removed before analysis.

How to find out more

Ourania Kaltsogianni, MD (Res)

ourania.kaltsogianni@nhs.net 0044+02032999000 Official trial record

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