Closed-Loop Automatic Oxygen Control (CLAC) in Preterm Infants: A Randomized Controlled Trial

Abstract

In preterm infants receiving supplemental oxygen, routine manual control (RMC) of the fraction of inspired oxygen (FIO2) is often difficult and time consuming. We developed a system for closed-loop automatic control (CLAC) of the FIO2 and demonstrated its short-term safety and efficacy in a single-center study. The objective of this study was to test the hypothesis that this system is more effective than RMC alone in maintaining arterial oxygen saturation within target levels when evaluated over 24 hours under routine conditions and with different target levels. We performed a multicenter, randomized controlled, crossover clinical trial in 34 preterm infants receiving mechanical ventilation or nasal continuous positive airway pressure and supplemental oxygen. Twenty-four-hour periods with RMC were compared with 24-hour periods of RMC supported by CLAC. The median (range) percentage of time with arterial oxygen saturation levels within target range was 61.4 (31.5-99.5) for RMC and 71.2 (44.0-95.4) for CLAC (P < .001). The median (range) number of manual FIO2 adjustments was reduced from 77.0 (0.0-224.0) for RMC to 52.0 (10.0-317.0) for CLAC (P = .007). CLAC may improve oxygen administration to preterm infants receiving mechanical ventilation or nasal continuous positive airway pressure while reducing workload related to RMC.