Does Closed-loop Automated Oxygen Control Reduce the Duration of Mechanical Ventilation? A Randomised Controlled Trial in Ventilated Preterm Infants

What this Trial Is About

Researchers are studying premature infants born before 31 weeks gestation who require mechanical ventilation shortly after birth. The trial compares two methods of controlling oxygen levels: manual adjustment by clinical staff versus a software called closed-loop automated oxygen control (CLAC) that automatically adjusts oxygen based on saturation levels. The goal is to see if automated control can reduce the time infants spend on ventilation and potentially decrease related complications. Participants will be randomly assigned to either standard ventilation with manual oxygen control or ventilation supported by the OxyGenie closed-loop oxygen software, which uses an algorithm to maintain oxygen saturation within target ranges. Manual adjustments remain possible if needed. The study continues from enrollment within 48 hours of starting ventilation until successful extubation. If reintubation occurs within 48 hours for infants under 28 days old, they remain in their original group. Those ventilated beyond 28 days continue in their assigned arm until extubation. During the study, researchers will monitor time spent on mechanical ventilation, oxygen saturation within target ranges, number of oxygen adjustments, days on oxygen, length of intensive care stay, and diagnosis of bronchopulmonary dysplasia at 36 weeks postmenstrual age. Data will be collected until study completion, averaging two years. Parents or legal guardians provide consent, and clinical assessments include epidemiologic factors and comorbidities that may influence ventilation duration.

Optimising Ventilation in Preterms With Closed-loop Oxygen Control