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The NIRS (near infrared spectroscopy) sensor will be applied to the abdomen of the study population. To ensure good skin contact the sensor will be placed underneath the diaper. If that should not provide enough measurement stability, additional fixation will be given by employing aforementioned flexible bandage routinely employed in neonatal care. Once good skin contact is ensured, the sensor will measure aStO2 (abdominal tissue oxygen saturation) for up to seventy-two hours. The presence of this sensor will not disturb daily clinical activities or medical treatment in any way. Should good skin contact be endangered by movements, clinical interactions or such, the sensor will be removed and re-attached to the infants' abdomen as a consequence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTOM | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tissue Oxygenation Monitoring | Device | The NIRS sensor will be applied to the abdomen of the study population. To ensure good skin contact the sensor will be placed underneath the diaper. If that should not provide enough measurement stability, additional fixation will be given by employing aforementioned flexible bandage routinely employed in neonatal care. Once good skin contact is ensured, the sensor will measure aStO2 for up to seventy-two hours. The presence of this sensor will not disturb daily clinical activities or medical treatment in any way. Should good skin contact be endangered by movements, clinical interactions or such, the sensor will be removed and re-attached to the infants' abdomen as a consequence. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of aStO2 measurements in all patients | aStO2 values calculated with and without considering the presence of additional absorbers besides haemoglobin. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the investigational device assessed by evaluation of adverse events | Evaluation of AEs (Adverse Event) with regard to the investigational device. The safety related to application and use of the NIRS sensors is aimed for. | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsspital Zürich | Zurich | Canton of Zurich | 8091 | Switzerland |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 7, 2023 | |
| Reset | May 24, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 7, 2023 | May 24, 2024 |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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