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This study uses a randomized crossover design to study the performance of an automatic oxygen control device compared to manual control by nurses. Inspired oxygen is controlled with the goal of maintaining the blood oxygen saturation in a desired range. Prematurely born infants in the hospital neonatal intensive care unit (NICU) will be included in the study.
This is a randomized crossover study to show that an automated oxygen control device performance is no worse than a NICU nurse in keeping a premature neonate's SPO2 within the prescribed range. Since subjects receive the device (automatic oxygen control) and the standard of care (manual control by a nurse), every subject serves as their own perfectly matched control. Performance measures include the average time it takes for the SpO2 to return to the desired range (primary endpoint) and the total amount of time that the SpO2 is within the desired range (secondary endpoint). The device will be applied to premature infants on respiratory support humidified high flow nasal cannula (HFNC) with oxygen controlled using a blend valve. Two groups include one that begins the study period with the device and one that begins the study period without the device. The two groups are switched between manual and automatic every 6 hours into the trial period and complete a total of 6 days. The target number of subjects is 48. We will analyze the study as a superiority trial if there is strong evidence of superiority.
Automatic control of inspired oxygen
Studer Family Children's Hospital at Sacred Heart
Not yet recruiting
University of Missouri-Columbia
Published on BioPortfolio: 2020-02-19T18:28:37-0500
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An abnormal increase in the amount of oxygen in the tissues and organs.
Automatic, mechanical, and apparently undirected behavior which is outside of conscious control.
Automatic or hand operated equipment used to control and extinguish fires.
Data processing largely performed by automatic means.
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