Clinical Evaluation of a Closed Loop Oxygen Controller for Neonatal Respiratory Care

Study Summary

Nearly forty years ago Berran and coworkers tested an analog oxygen controller to maintain incubator oxygen levels for infants suffering neonatal respiratory disease in order to prevent hyperoxia. There are at least three clinical issues that this technology addresses: the first is avoidance of episodic hyperoxia; the second is decreasing episodic hypoxia; and the third is lowering cumulative oxygen exposure. Clinical trials which have used target SpO2 ranging probably help improve all of these problems, but so far there have been no direct measurements of continuous arterial oxygen levels, nor clinical studies which establish the degree to which improving control over blood oxygen saturation decreases the cumulative amount of oxygen exposure. This study will address the later and is an important step in the process of incorporating closed-loop oxygen control technology as a routine standard of neonatal respiratory care. OBJECTIVES: PART 1: Test and modify the instruction set for the computerized oxygen controller to achieve a goal of less than six (6) operator required interruptions per hour for oxygen saturation deviations outside of study guidelines. PART 2: Perform a within patient cross-over trial of the computerized oxygen controller versus standard of care (the patient's care team adjusts the patient's oxygen level) and evaluate the area under the time curve for oxygen exposure between the two control methods. PART 3:(After successful completion of PART 2) Continuation of the within patient cross-over study with a randomized cross-over sequence. Studies will last 4 to 12 hours divided in two (2) equal time blocks with one cross-over to either automatic or manual control modes. Provision for up to an additional twenty (20) patients to be studied.