Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
117 participants
INTERVENTIONAL
2010-08-04
2022-06-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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precision and accuracy study
precision and accuracy of Oxyprem are studied
Measurement of tissue oxygenation with novel diagnostic near-infrared spectroscopy device (OxyPrem) (no clinical decisions based on oxygenation levels)
The precision of OxyPrem is assessed by repeated measurements of tissue oxygenation and hemoglobin concentration. The accuracy of OxyPrem is assessed by comparing the measurement data to those acquired simultaneously by established NIRS devices and standard clinical monitoring devices. In substudy 1, healthy adult subjects are enrolled, in substudy 2, measurements are conducted on preterm neonates.
Interventions
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Measurement of tissue oxygenation with novel diagnostic near-infrared spectroscopy device (OxyPrem) (no clinical decisions based on oxygenation levels)
The precision of OxyPrem is assessed by repeated measurements of tissue oxygenation and hemoglobin concentration. The accuracy of OxyPrem is assessed by comparing the measurement data to those acquired simultaneously by established NIRS devices and standard clinical monitoring devices. In substudy 1, healthy adult subjects are enrolled, in substudy 2, measurements are conducted on preterm neonates.
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent
* Pre-term neonates (gestational age at birth less than 37 weeks)
* Signed informed consent by at least one parent
Exclusion Criteria
* Neurological diseases.
Substudy 2 (preterm infants)
* Clinically instability
* Malformations
ALL
Yes
Sponsors
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Hans Ulrich Bucher
OTHER
Responsible Party
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Hans Ulrich Bucher
Principal Investigator
Principal Investigators
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Bucher, Prof.em.
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Locations
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University Hospital of Zurich
Zurich, Canton of Zurich, Switzerland
Countries
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Other Identifiers
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PB_2016-00395
Identifier Type: -
Identifier Source: org_study_id
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