NCT01942473

Effects of Automated Adjustment of FiO2 on Cerebral and Arterial Oxygenation in Preterm Infants

Effects of Automated Adjustment of Inspired Oxygen on Fluctuations of Regional Cerebral and Arterial Oxygenation in Preterm Infants With Frequent Desaturations

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of Ulm · Academic / Other
• Sex: All
• Age: 96 Hours – 30 Weeks
• Healthy volunteers: Not accepted

Summary

In this study the investigators test the hypothesis that automated FiO2 adjustment increases the time of brain tissue oxygenation within the intended reference range. Furthermore, the investigators studied the change in workload during automated FiO2 adjustment as compared to manual adjustment by the nursing staff.

Detailed description

Recorded data on brain tissue oxygenation will be compared with reference data obtained from other studies. Data from experimental mode (automated FiO2 control will be compared with manual FiO2 control).

Conditions

• Preterm Infant
• RDS

Interventions

Type	Name	Description
DEVICE	Automated FiO2 Control	Infants will be ventilated with or without automated FiO2-Control in a randomized sequence.

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-09-01
• Completion: 2014-04-01
• First posted: 2013-09-16
• Last updated: 2014-11-26

Locations

1 site across 1 country: Germany