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Clinical Trial Summary

The overall objective of this study is to demonstrate that the IntellO2 device providing automated control of fraction of inspired oxygen (FiO2) adjustments in spontaneously breathing infants with fluctuating arterial blood oxygen saturation levels is safe and efficacious in the routine clinical environment. Specifically, it is hypothesized that the IntellO2 will perform as well or better than standard practice for maintaining infants' arterial blood oxygen saturation in a target range while minimizing the exposure to elevated levels of oxygen in the inspired gas.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02074774
Study type Interventional
Source Vapotherm, Inc.
Contact
Status Completed
Phase N/A
Start date December 2016
Completion date January 2018