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Cerebral Oximetry in Newborns - Comparing INVOS 5100c and OxyPrem vs. 1.2

NCT01771601 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2013-10-07

No results posted yet for this study

Summary

Regional tissue oxygenation (cStO2) can be monitored by near infrared spectroscopy. The commercial device INVOS 5100 (COVIDIEN, Mansfield, MA, USA) and the prototype OxyPrem vs. 1.2 (Biomedical Optics Research Laboratory, Zurich, Switzerland) will be used simultaneously to test for their relative sensitivity for low oxygen levels just after birth on term infants born by elective caesarean section. Reproducibility will be examined by replacements of the sensors six times the next day when the infant is stable and quiet. The Adult Somasensor (INVOS) will be used together with the OxyPrem sensor.

Conditions

  • Near-infrared Spectroscopy, Transition, Caesarean Section

Sponsors & Collaborators

  • The Augustinus Foundation, Denmark.

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Eligibility

Max Age
10 Minutes
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01771601 on ClinicalTrials.gov