Active not recruitingPHASE3INTERVENTIONAL

Effects of Closed-loop Automatic Control of FiO2 in Extremely Preterm Infants

This study is for very premature babies, those born before 28 weeks. These babies often have challenges keeping their oxygen levels steady, leading to drops and spikes that can harm their development or cause problems like eye damage (retinopathy of prematurity). Doctors usually adjust oxygen levels by hand, which can be difficult and time-consuming. Researchers are testing a new automatic system that helps keep oxygen levels stable. The study will compare babies who receive oxygen with this automatic system alongside manual adjustments, to babies who only receive manual oxygen adjustments. The main goal is to find out if the automatic system can reduce serious health problems and improve the long-term well-being of these vulnerable infants.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

University Hospital Tuebingen

Enrolment target

1,065

Start

27 Jul 2018

Estimated completion

01 Dec 2026

Infant,Premature

What is this study about?

When babies are born very early, especially before 28 weeks of pregnancy, their bodies are not yet fully developed. One of the biggest challenges for these tiny infants is keeping their oxygen levels just right. Their breathing can be irregular, and their oxygen levels in the blood can go too low (called hypoxemia) or too high (called hyperoxemia). These swings in oxygen levels, whether too little or too much, can be harmful and have been linked to serious problems, including vision issues like retinopathy of prematurity (ROP), problems with development as they grow up, and even a higher risk of death.

Current hospital care involves nurses and doctors regularly checking the baby's oxygen levels and manually adjusting the amount of oxygen they receive. This is a very important job, but it's also very challenging and often time-consuming because oxygen levels can change quickly. It can be hard to keep up with these rapid changes, especially with many other tasks to do, and sometimes it's impossible to always keep the oxygen exactly where it needs to be.

This study is looking at a new technology: an automated system that can adjust a baby's oxygen much more frequently and precisely than a person can. It's like an autopilot for oxygen. Early smaller studies have suggested that these automatic systems help keep oxygen levels more stable and can reduce the number and length of time babies spend with oxygen levels that are too low or too high. This study, which is larger, aims to see if using this automatic system, along with the usual manual adjustments, can make a real difference in the health and long-term development of these very premature babies compared to just using manual adjustments.

Key takeaways

New study focuses on extremely premature babies (born before 28 weeks).
It tests an automatic system for oxygen control against manual adjustments.
Goal is to improve babies' health and reduce long-term complications.
All participating babies will receive high-quality medical care.
Participation involves ongoing monitoring of the baby's health and development.

Who may be eligible?

To be part of this study, babies must have been born very prematurely, specifically between 23 weeks and zero days, and 27 weeks and six days of pregnancy. They also need to be enrolled in the study within 48 hours of their birth.

Babies would not be able to join the study if there has been a decision by their parents and medical team to provide only comfort care (palliative care). They also can't participate if they have certain birth defects or if their parents don't give their consent for them to be in 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 your baby born between 23 weeks and zero days, and 27 weeks and six days of pregnancy?
Was your baby admitted to the study within 48 hours of birth?
Has there been no decision for comfort-only care for your baby?
Does your baby not have certain major birth defects?
Are you able to provide consent for your baby to participate?

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 either receive oxygen treatment with the new automatic system plus manual adjustments by their care team, or they would receive oxygen treatment solely with manual adjustments by their care team, which is the standard method. The decision of which group your baby is in will be made randomly, like flipping a coin. Both groups will receive the best possible medical care.

The study will follow your baby closely while they are in the hospital. Doctors and nurses will continue their usual monitoring, and the study will gather information on how your baby is doing, including their oxygen levels and overall health. Afterwards, data will be collected on their development for some time, to see if there are any long-term differences between the two groups. The total duration of follow-up for development will be explained by the study team.

Potential risks and benefits

Participating in this study might offer a potential benefit if the automatic oxygen control system proves to be more effective at stabilising oxygen levels and improving health outcomes for your baby. However, there's also a chance there might be no special benefit, or that there could be unexpected risks, though the new system is designed to be safe and has shown promise. All treatments carry some level of risk. You have the right to withdraw your baby from the study at any time, for any reason, without it affecting their medical care.

Locations (32)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Northwest Women's and Children's Hospital
Verified postcode
Xi'an, China
Klinikum St. Marien - Klinik für Kinder und Jugendliche
Verified postcode
Amberg, Germany
Josefinum - Klinik für Kinder und Jugendliche
Verified postcode
Augsburg, Germany
Diakonie Krankenhaus der Kreuznacher Diakonie
Verified postcode
Bad Kreuznach, Germany
Klinikum Links der Weser
Verified postcode
Bremen, Germany
Universitätsklinikum Dresden
Verified postcode
Dresden, Germany
Universitätsklinikum Düsseldorf
Verified postcode
Düsseldorf, Germany
HELIOS Klinikum Erfurt
Verified postcode
Erfurt, Germany
Klinikum Esslingen GmbH - Klinik für Kinder und Jugendliche
Verified postcode
Esslingen am Neckar, Germany
Zentrum für Kinder- und Jugendmedizin
Verified postcode
Freiburg im Breisgau, Germany
Medizinische Hochschule Hannover
Verified postcode
Hanover, Germany
Universitätsklinikum Heidelberg
Verified postcode
Heidelberg, Germany

Common questions

What kind of babies are typically involved in this research?

This research focuses on very premature babies, those born before 28 weeks of pregnancy.

What is 'closed-loop automatic control of FiO2'?

It's a smart system that automatically adjusts the amount of oxygen a baby receives, aiming to keep their oxygen levels steady and within a healthy range.

Why is stable oxygen so important for premature babies?

Keeping oxygen levels stable helps protect premature babies from serious problems like eye damage and issues with their long-term development.

Will my baby still get standard medical care if we join the study?

Yes, all babies in the study will receive the highest standard of medical care, regardless of which group they are in.

What happens if I change my mind about my baby being in the study?

You can withdraw your baby from the study at any time, and it will not affect their medical care in any way.