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

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. Identifier: NCT01665287
Recruitment Status : Completed
First Posted : August 15, 2012
Last Update Posted : January 15, 2013
The Augustinus Foundation, Denmark.
Information provided by (Responsible Party):
Gorm Greisen, Rigshospitalet, Denmark

Brief Summary:
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 or disease
Near Infrared Spectroscopy

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Study Type : Observational
Estimated Enrollment : 12 participants
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..
Study Start Date : August 2012
Actual Study Completion Date : November 2012

Primary Outcome Measures :
  1. 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 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Term infants born by elective cesarian section.

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)

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 identifier (NCT number): NCT01665287

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Department of Neonatology, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
The Augustinus Foundation, Denmark.
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Principal Investigator: Gorm Greisen, Professor Not relevant

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Responsible Party: Gorm Greisen, Professor, MD, Rigshospitalet, Denmark Identifier: NCT01665287     History of Changes
Other Study ID Numbers: 300712FORVOS
First Posted: August 15, 2012    Key Record Dates
Last Update Posted: January 15, 2013
Last Verified: January 2013
Keywords provided by Gorm Greisen, Rigshospitalet, Denmark:
Cerebral Oximetry
Near infrared spectroscopy