Randomized Trial of Automated Oxygen Control in Preterm Infants Under 34 Weeks on Non-Invasive Respiratory Support

What this Trial Is About

This trial studies preterm infants born before 34 weeks of gestation who require non-invasive respiratory support. It compares closed-loop automated oxygen control CLAC with manual oxygen control to see if CLAC can reduce the time infants need supplemental oxygen and improve how well oxygen levels are kept within target ranges. The study also looks at whether CLAC lowers risks of low or high oxygen levels, reduces manual adjustments to oxygen settings, and decreases complications like bronchopulmonary dysplasia BPD. Participants will be randomly assigned to either automated oxygen control using the OxyGenie software or to manual oxygen control. Both groups receive non-invasive support such as nasal CPAP, non-invasive positive pressure ventilation, or humidified high flow nasal cannula oxygen. Oxygen settings are adjusted as needed by clinical staff. The study is conducted at a single hospital neonatal intensive care unit and includes continuous monitoring with standard bedside monitors and specialized sensors. Parents provide consent for infants to join soon after starting non-invasive respiratory support, and infants are followed until they stop needing this support, reach 36 weeks postmenstrual age, or are discharged. Researchers will track time spent on ventilation, oxygen saturation within target ranges, low and high oxygen episodes, number of manual oxygen adjustments, total oxygen treatment duration, length of hospital stay, and occurrence of BPD at 36 weeks. This comprehensive monitoring aims to assess how automated oxygen control affects infant outcomes during their early care.

Automated Oxygen Control in Preterms on Non-invasive Ventilation