Ongoing Clinical Trials for Neonatal Death
Currently, there is 1 ongoing clinical trial focused on preventing complications that can lead to neonatal death in extremely preterm infants. This trial is testing an automatic oxygen control system for babies born between 23 and 27 weeks of pregnancy, aiming to improve survival and reduce serious complications such as eye disease, lung disease, and intestinal problems that can affect these vulnerable newborns.
Clinical trial locations
Study on Automatic Oxygen Control for Extremely Preterm Infants Using Oxygen PH.EUR.
This clinical trial is investigating a new approach to managing oxygen levels in extremely preterm infants born between 23 and 27 weeks of pregnancy. The study is taking place in Germany and focuses on comparing an automatic oxygen control system with the traditional manual method used by healthcare providers.
Main inclusion criteria:
- Babies born between 23 weeks and 0 days and 27 weeks and 6 days of pregnancy
- Both male and female infants can participate
- The study includes vulnerable newborns who may need special care or protection
Main exclusion criteria:
While specific exclusion criteria are not detailed in the available information, the trial focuses specifically on this narrow gestational age range of extremely preterm infants.
Focus and goals:
The trial aims to determine whether an automatic system that adjusts oxygen levels can improve outcomes for extremely preterm babies compared to manual adjustments by healthcare staff. The right amount of oxygen is crucial for these infants’ health and development. Too much or too little oxygen can lead to serious complications.
The study will evaluate whether the automatic system can reduce the risk of several serious conditions, including:
- Retinopathy of prematurity – a serious eye condition where abnormal blood vessels grow in the retina, potentially causing vision problems or blindness
- Chronic lung disease – also known as bronchopulmonary dysplasia, which causes inflammation and scarring in the lungs, leading to breathing difficulties
- Necrotizing enterocolitis – a severe intestinal disease involving inflammation and tissue death in the intestine
The trial will also monitor overall survival and development of the infants up to 24 months after their expected due date. At this 24-month follow-up, researchers will assess neurodevelopmental outcomes, including motor abilities, language and cognitive development, and any visual or hearing impairments.
Investigational treatment:
The trial is testing a closed-loop automatic control system for adjusting 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 maintains appropriate oxygen levels in the infant’s blood without requiring constant manual adjustments by healthcare providers.
Infants enrolled in the study are randomly assigned to one of two groups: one receiving the automatic oxygen control and the other receiving manual adjustments. Throughout their hospital stay, infants receive oxygen therapy through standard infant ventilators, with regular monitoring to ensure safety and effectiveness.
Summary
This single ongoing trial represents an important effort to improve outcomes for extremely preterm infants, one of the most vulnerable patient populations. The study is taking place in Germany and focuses on refining a critical aspect of neonatal care – oxygen delivery – which can significantly impact survival and long-term health outcomes.
The trial’s comprehensive approach includes not only immediate hospital outcomes but also long-term developmental assessment at 24 months, providing valuable information about how early oxygen management may influence growth and development. If successful, this automatic oxygen control system could represent an advancement in neonatal intensive care, potentially reducing the burden on healthcare providers while improving consistency in oxygen delivery to these fragile newborns.
