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

NCT ID: NCT01665287

Last Updated: 2013-01-15

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

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Near Infrared Spectroscopy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Maximum Eligible Age

2 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, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gorm Greisen, Professor

Role: PRINCIPAL_INVESTIGATOR

Not relevant

Locations

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Department of Neonatology, Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Noori S, Wlodaver A, Gottipati V, McCoy M, Schultz D, Escobedo M. Transitional changes in cardiac and cerebral hemodynamics in term neonates at birth. J Pediatr. 2012 Jun;160(6):943-8. doi: 10.1016/j.jpeds.2011.12.008. Epub 2012 Jan 11.

Reference Type BACKGROUND
PMID: 22244465 (View on PubMed)

Kratky E, Pichler G, Rehak T, Avian A, Pocivalnik M, Muller W, Urlesberger B. Regional cerebral oxygen saturation in newborn infants in the first 15 min of life after vaginal delivery. Physiol Meas. 2012 Jan;33(1):95-102. doi: 10.1088/0967-3334/33/1/95.

Reference Type BACKGROUND
PMID: 22173332 (View on PubMed)

Urlesberger B, Kratky E, Rehak T, Pocivalnik M, Avian A, Czihak J, Muller W, Pichler G. Regional oxygen saturation of the brain during birth transition of term infants: comparison between elective cesarean and vaginal deliveries. J Pediatr. 2011 Sep;159(3):404-8. doi: 10.1016/j.jpeds.2011.02.030. Epub 2011 Apr 9.

Reference Type BACKGROUND
PMID: 21481417 (View on PubMed)

Urlesberger B, Grossauer K, Pocivalnik M, Avian A, Muller W, Pichler G. Regional oxygen saturation of the brain and peripheral tissue during birth transition of term infants. J Pediatr. 2010 Nov;157(5):740-4. doi: 10.1016/j.jpeds.2010.05.013. Epub 2010 Jun 17.

Reference Type BACKGROUND
PMID: 20955848 (View on PubMed)

Other Identifiers

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300712FORVOS

Identifier Type: -

Identifier Source: org_study_id

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