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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Automated FiO2 control | Experimental | Infants will be changed to a specific ventilator device approved for clinical use in neonates in Germany (Avea, Carefusion 234 GmbH Hoechberg, Germany), which is capable to automatically adjust the FiO2 based on readings of an incorporated SpO2 monitoring device. Infants will be allowed to adjust for at least 2h using the ventilator settings as chosen by the clinical team responsible. Thereafter, data will be recorded for 24h experimental time. |
|
| Manual Adjustment | Placebo Comparator | Infants will be exposed to the first study phase (clinical routine or automated FiO2 adjustment) for 24 h and then will be switched to the alternate mode (automated FiO2 adjustment or clinical routine) for another 24 h. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated FiO2 Control | Device | Infants will be ventilated with or without automated FiO2-Control in a randomized sequence. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral tissue oxygen saturation | mean cerebral tissue oxygen saturation as well als distribution of cerebral tissue oxygen saturation over time will be assessed | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| number and mean duration of episodes with an SpO2 <80%, <75%, <70% and with hyperoxemia (SpO2 >96%) | The number and mean duration of expisodes of desaturation and with hyperoxemia will be assessed | 48 hours |
| time within a defined target range of cerebral oxygen saturation (59% - 81%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markus Waitz, MD | Children's Hospital, University of Ulm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital University of Ulm | Ulm | 89070 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25454938 | Derived | Waitz M, Schmid MB, Fuchs H, Mendler MR, Dreyhaupt J, Hummler HD. Effects of automated adjustment of the inspired oxygen on fluctuations of arterial and regional cerebral tissue oxygenation in preterm infants with frequent desaturations. J Pediatr. 2015 Feb;166(2):240-4.e1. doi: 10.1016/j.jpeds.2014.10.007. Epub 2014 Nov 18. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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time (as measured as the percentage of the total recording time) within a defined target range of cerebral oxygen saturation (59% - 81%) which corresponds to the 10th and 90th percentile obtained from a pilot study in 16 preterm infants with desaturations during the time when their SpO2 was aimed within the target range of a SpO2 of (88-96%). |
| 48 hours |
| workload for the medical staff related to number of adjustments of FiO2 | 48 hours |
| D000091642 | Urogenital Diseases |