In this randomized crossover trial, preterm infants with intermittent hypoxemia and need for supplemental oxygen will be randomized to either Sequence of two different oxygen target ranges (low: 85-89%; high: 91-95%) for a total duration of 19 hours. Cerebral oxygenation, cardiac output, arterial oxygenation and heart rate will be measured continuously. Primary outcome is time with arterial oxygen saturation \< 80%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Adapt inspired oxygen to achieve desired SpO2 target range
University Medical Center, Ulm University
Ulm, Baden-Wurttemberg, Germany
RECRUITINGDuration SpO2 < 80%
Time frame: during 16 hours of measurement
Cerebral tissue oxygen saturation as measured by NIRS
Area under threshold
Time frame: during 16 hours of measurement
Arterial SpO2 as measured by pulse oxymetry
Area under 80%
Time frame: during 16 hours of measurement
Heart rate as measured by ECG
Area under 80/min
Time frame: during 16 hours of measurement
cerebral and visceral fractional oxygen extraction as measured by NIRS
Time frame: during 16 hours of measurement
Cardiac output as measured by Cardiovelocimetry
Time frame: during 16 hours of measurement
Number of hypoxemic and / or bradycardic events
Time frame: during 16 hours of measurement
Visceral tissue oxygen saturation as measured by NIRS
Area under threshold
Time frame: during 16 hours of measurement
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