Optimising Ventilation in Preterms With Closed-loop Oxygen Control

Many premature infants require respiratory support in the newborn period. Mechanical ventilation although life-saving is linked to complications for the lungs and other organs and its duration should be kept to a minimum. The use of supplemental oxygen may also increase the risk of comorbidities such as retinopathy of prematurity. Therefore, oxygen saturation levels and the amount of inspired oxygen concentration provided should be continuously monitored. Oxygen control can be performed manually or with the use of a computer software incorporated into the ventilator that is called 'closed loop automated oxygen control'(CLAC). The software uses an algorithm that automatically adjusts the amount of inspired oxygen to maintain oxygen saturation levels in a target range. Evidence suggests that CLAC increases the time spent in the desired oxygen target range but there are no data to determine the effect on important clinical outcomes. A previous study has also demonstrated that CLAC reduces the inspired oxygen concentration more rapidly when compared to manual control. That could help infants come off the ventilator sooner. With this study we want to compare the time preterm infants spend on the ventilator when we use the software to automatically monitor their oxygen levels with those infants whose oxygen is adjusted manually by the clinical team. That could help us understand if the use of automated oxygen control reduces the duration of mechanical ventilation and subsequently the complications related to it.

NCT Number	NCT05030337
Lead Sponsor	King's College Hospital NHS Trust Collaborators: King's College London
Conditions	Infant, Premature, Diseases, Airway Morbidity, Mechanical Ventilation Complication
Enrollment	70 participants
Start Date	2021-09-05
Primary Completion	2025-03 (estimated)
Study Completion	2025-03 (estimated)
Updated on ClinicalTrials.gov	2024-10-23