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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
36
Automated FiO2 regulator that responds to pulse oximetry measures
Standard practice of manually titrating FiO2 as needed.
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, United Kingdom
Ashford and St. Peter's Hospitals NHS Trust
Chertsey, Surrey, United Kingdom
Percent time in target range for oxygen saturation by pulse oximetry
Time frame: 24 hrs
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