NIRS to Monitor Abdominal Tissue Oxygen Saturation in Preterm Infants (CTOM FIH)
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|ClinicalTrials.gov Identifier: NCT03706976|
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : August 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Disorder||Device: Tissue Oxygenation Monitoring||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||NIRS to Monitor Abdominal Tissue Oxygen Saturation in Preterm Infants in an Open Mono-centric Study|
|Actual Study Start Date :||April 30, 2019|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||December 2021|
Device: Tissue Oxygenation Monitoring
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.
- Feasibility of aStO2 measurements in all patients [ Time Frame: 72 hours ]aStO2 values calculated with and without considering the presence of additional absorbers besides haemoglobin.
- Safety of the investigational device assessed by evaluation of adverse events [ Time Frame: 72 hours ]Evaluation of AEs with regard to the investigational device. The safety related to application and use of the NIRS sensors is aimed for.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706976
|Contact: Jérôme Bernhard, MSc ETHfirstname.lastname@example.org|
|Zürich, ZH, Switzerland, 8091|