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

NCT ID: NCT01771601

Last Updated: 2013-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Near-infrared Spectroscopy, Transition, Caesarean Section

Keywords

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Near-infrared spectroscopy, cerebral oxygenation, term newborn, reproducibility,

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Near-infrared spectroscopy sensors

Term infants born by elective Caesarean section

No interventions assigned to this group

Eligibility Criteria

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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)
Maximum Eligible Age

10 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Augustinus Foundation, Denmark.

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Gorm Greisen

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gorm Greisen

Copenhagen, Copenhagen, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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090113OXYVOS

Identifier Type: -

Identifier Source: org_study_id