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Cerebral Oximetry in Newborns - Comparing INVOS 5100 and FORE-SIGHT Cerebral Oximeters

This study has been completed.
Sponsor:
Collaborator:
The Augustinus foundation
Information provided by (Responsible Party):
Gorm Greisen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01665287
First received: August 13, 2012
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

Regional tissue oxygenation (rStO2) can be monitored by near infrared spectroscopy. The commercial devices FORE-SIGHT (CASMED) and INVOS (COVIDIEN) will be used simultaneously to test for their relative sensitivity for low oxygen levels just after birth on term infants born by elective cesarean section. Reproducibility will be examined by replacements of the sensors six times the next day when the infant is stable and quiet. Neonatal sensors will be used.


Condition
Near Infrared Spectroscopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cerebral Oximetry in Newborns - Comparing INVOS 5100 and FORE-SIGHT Cerebral Oximeters Absolute Values, Sensitivity for Low Oxygen Levels and Reproducibility..

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

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 or by self-adhesive tape as appropriate.

    Curve fitting will be used to describe the rapid increase of oxygenation after birth. Estimated cerebral oxygenation at 3 min (hypoxia) and 10 min (normoxia) will be used to compare the two instruments.



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.


Estimated Enrollment: 12
Study Start Date: August 2012
Study Completion Date: November 2012
  Eligibility

Ages Eligible for Study:   up to 2 Minutes
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Term infants born by elective cesarian section.

Criteria

Inclusion Criteria:

  • Term infants (age more than 37 weeks of gestation)
  • Elective cesarean section after an uncomplicated pregnancy

Exclusion criteria:

  • Thick hair that makes good measurements difficult/impossible
  • Obvious malformations or syndrome
  • Complications in relation to the cesarean section
  • Depression after birth (APGAR < 8 after 1 minute)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665287

Locations
Denmark
Department of Neonatology, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
The Augustinus foundation
Investigators
Principal Investigator: Gorm Greisen, Professor Not relevant
  More Information

Publications:

Responsible Party: Gorm Greisen, Professor, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01665287     History of Changes
Other Study ID Numbers: 300712FORVOS
Study First Received: August 13, 2012
Last Updated: January 14, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Cerebral Oximetry
Near infrared spectroscopy
Fullterm
Infant

ClinicalTrials.gov processed this record on May 23, 2013