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

This study has been completed.
Sponsor:
Collaborator:
The Augustinus foundation
Information provided by (Responsible Party):
Gorm Greisen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01771601
First received: January 16, 2013
Last updated: September 30, 2013
Last verified: September 2013
  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 Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Cerebral oxygenation [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   up to 10 Minutes
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01771601

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

No publications provided

Responsible Party: Gorm Greisen, professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01771601     History of Changes
Other Study ID Numbers: 090113OXYVOS
Study First Received: January 16, 2013
Last Updated: September 30, 2013
Health Authority: Denmark: Danish Health and Medicines Authority
Denmark: The regional Danish ethical committee
Denmark: The Danish Data protection agency

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

ClinicalTrials.gov processed this record on April 21, 2014