Ongoing Clinical Trials for Necrotising Enterocolitis Neonatal
There is currently 1 ongoing clinical trial focused on preventing necrotising enterocolitis neonatal and other serious complications in extremely preterm infants through improved oxygen delivery methods. This trial is investigating an automatic oxygen control system for babies born between 23 and 27 weeks of pregnancy, comparing it to traditional manual oxygen adjustments to potentially improve survival and reduce the risk of severe complications.
Clinical trial locations
Study on Automatic Oxygen Control for Extremely Preterm Infants Using Oxygen PH.EUR.
This trial is testing a new automatic system for controlling oxygen levels in extremely preterm infants born between 23 and 27 weeks of pregnancy. The study compares this automatic system with the traditional method where healthcare providers manually adjust the oxygen levels.
Main inclusion criteria: The trial accepts male and female infants born between 23 weeks and 0 days and 27 weeks and 6 days of pregnancy. These babies are considered a vulnerable population requiring special care and protection.
Main exclusion criteria: The source data does not provide specific exclusion criteria, but participation is limited to the specific gestational age range mentioned above.
Focus and goals: The primary goal is to determine whether the automatic oxygen control system can improve outcomes for extremely preterm infants compared to manual adjustments. The study specifically aims to reduce the risk of serious complications including retinopathy of prematurity (a severe eye condition that can lead to vision loss), chronic lung disease (also called bronchopulmonary dysplasia, which causes breathing difficulties), and necrotising enterocolitis (a severe intestinal disease). The trial also monitors overall survival and tracks the infants’ development until they reach 24 months corrected age, assessing motor skills, language development, cognitive abilities, and checking for any severe visual or hearing impairments.
Investigational treatment: The treatment being tested is called closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C). This technology is built into standard infant ventilators and automatically adjusts the amount of oxygen that extremely preterm infants receive during mechanical ventilation or other forms of breathing support. The system works by continuously monitoring and maintaining the right oxygen levels in the infant’s blood without needing constant manual adjustments by healthcare providers. This is compared to the usual method where staff manually adjust oxygen levels based on monitoring.
The trial follows participating infants throughout their hospital stay, with regular monitoring to ensure safety and effectiveness. After discharge, there is a long-term follow-up assessment at 24 months corrected age to evaluate how well the children are developing.
Summary
Currently, there is only one ongoing clinical trial specifically addressing necrotising enterocolitis neonatal as part of a broader study on complications in extremely preterm infants. This trial is being conducted in Germany and focuses on improving oxygen delivery through automatic control systems. The research is particularly important because proper oxygen management is crucial for preventing multiple serious complications in very premature babies, including necrotising enterocolitis, eye problems, and lung disease. The trial takes a comprehensive approach by not only monitoring immediate outcomes during hospitalization but also tracking developmental progress until two years of age, providing valuable long-term data on the effectiveness of this new oxygen control method.
