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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, Denmark.
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

August 13, 2012
January 14, 2013
August 2012
Not Provided
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.

Cerebral oxygenation [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01665287 on ClinicalTrials.gov Archive Site
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.
Reproducibility [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
The sensor will be placed 6 times alternating each frontoparietal region, 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.
Not Provided
Not Provided
 
Cerebral Oximetry in Newborns - Comparing INVOS 5100 and FORE-SIGHT Cerebral Oximeters
Cerebral Oximetry in Newborns - Comparing INVOS 5100 and FORE-SIGHT Cerebral Oximeters Absolute Values, Sensitivity for Low Oxygen Levels and Reproducibility..

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Term infants born by elective cesarian section.

Near Infrared Spectroscopy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
November 2012
Not Provided

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)
Both
up to 2 Minutes
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01665287
300712FORVOS
No
Gorm Greisen, Rigshospitalet, Denmark
Rigshospitalet, Denmark
The Augustinus Foundation, Denmark.
Principal Investigator: Gorm Greisen, Professor Not relevant
Rigshospitalet, Denmark
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP