This clinical trial is focused on studying the effects of a new method for controlling the amount of oxygen given to extremely preterm infants, who are babies born very early, between 23 and 27 weeks of pregnancy. The treatment being tested is called OXYGEN PH.EUR., which is a type of oxygen used in medical settings. The study aims to compare a new automatic system that adjusts the oxygen levels with the traditional manual method used by healthcare providers. This is important because the right amount of oxygen is crucial for the health and development of these infants.
The purpose of the study is to see if the automatic system can improve outcomes for these infants, such as reducing the risk of complications like retinopathy of prematurity (a serious eye condition), chronic lung disease, and necrotizing enterocolitis (a severe intestinal disease). The study will also look at the overall survival and development of the infants up to 24 months after their expected due date. The trial will involve monitoring the infants closely to see if the automatic system provides better results than the manual method.
Throughout the study, infants will receive oxygen through standard infant ventilators, which are machines that help them breathe. The trial will last until the infants are discharged from the hospital, and their development will be assessed at 24 months. This research is important to potentially improve the care and outcomes for extremely preterm infants by ensuring they receive the right amount of oxygen in a safe and effective way.



Germany