Cerebral Oximetry in Newborns - Comparing INVOS 5100 and FORE-SIGHT Cerebral Oximeters
This study has been completed.
Sponsor:
Rigshospitalet, Denmark
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
| Tracking Information | |||||
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| First Received Date ICMJE | August 13, 2012 | ||||
| Last Updated Date | January 14, 2013 | ||||
| Start Date ICMJE | August 2012 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE |
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. |
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| Change History | Complete list of historical versions of study NCT01665287 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE |
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. |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cerebral Oximetry in Newborns - Comparing INVOS 5100 and FORE-SIGHT Cerebral Oximeters | ||||
| Official Title ICMJE | Cerebral Oximetry in Newborns - Comparing INVOS 5100 and FORE-SIGHT Cerebral Oximeters Absolute Values, Sensitivity for Low Oxygen Levels and Reproducibility.. | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Term infants born by elective cesarian section. |
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| Condition ICMJE | Near Infrared Spectroscopy | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 12 | ||||
| Completion Date | November 2012 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion criteria:
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| Gender | Both | ||||
| Ages | up to 2 Minutes | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01665287 | ||||
| Other Study ID Numbers ICMJE | 300712FORVOS | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Gorm Greisen, Rigshospitalet, Denmark | ||||
| Study Sponsor ICMJE | Rigshospitalet, Denmark | ||||
| Collaborators ICMJE | The Augustinus foundation | ||||
| Investigators ICMJE |
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| Information Provided By | Rigshospitalet, Denmark | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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