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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01771601
First Posted: January 18, 2013
Last Update Posted: October 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Augustinus Foundation, Denmark.
Information provided by (Responsible Party):
Gorm Greisen, Rigshospitalet, Denmark
  Purpose
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.

Condition
Near-infrared Spectroscopy, Transition, Caesarean Section

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cerebral Oximetry in Newborns - Comparing INVOS 5100c and OxyPrem vs. 1.2's Absolute Values, Sensitivity for Low Oxygen Levels and Reproducibility

Resource links provided by NLM:


Further study details as provided by Gorm Greisen, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Cerebral oxygenation [ Time Frame: 10 minutes ]
    The sensors of both instruments will be placed on each side of the head. They will be held by hand by self-adhesive tape as appropriate.


Secondary Outcome Measures:
  • Reproducibility [ Time Frame: 10 minutes ]
    The sensor will be placed 6 times alternating on each frontoparietal region and held by hand, obtaining 30 seconds of signal for each placement. The placements will be in the same region but not in exactly the same spot. This will be done for both devices.


Enrollment: 24
Study Start Date: January 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Near-infrared spectroscopy sensors
Term infants born by elective Caesarean section

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 10 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy term infants born by elective caesarean section at Rigshospitalet, Denmark
Criteria

Inclusion Criteria:

  • Term infants
  • Elective caesarean section

Exclusion Criteria:

  • Thick hair that makes good measurements difficult/impossible
  • obvious malformations or syndromes
  • Complications in relation to caesarean section
  • Depression after birth (APGAR < 8 after 1 minute)
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01771601


Locations
Denmark
Gorm Greisen
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
The Augustinus Foundation, Denmark.
  More Information

Responsible Party: Gorm Greisen, professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01771601     History of Changes
Other Study ID Numbers: 090113OXYVOS
First Submitted: January 16, 2013
First Posted: January 18, 2013
Last Update Posted: October 7, 2013
Last Verified: September 2013

Keywords provided by Gorm Greisen, Rigshospitalet, Denmark:
Near-infrared spectroscopy, cerebral oxygenation, term newborn, reproducibility,