Cerebral Tissue Oxygenation Values in Newborns Measured Using Laser and LED NIRS Oximeters

NCT ID: NCT01496027

Last Updated: 2013-09-10

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

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-04-30

Brief Summary

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The aim of the study is to compare the values of cerebral tissue oxygenation measured simultaneously using laser light (FORE-SIGHT) and LED (INVOS) cerebral oximeters.

Detailed Description

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Conditions

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Cerebral Oxygenation

Keywords

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cerebral oxygenation NIRS tissue oximeters near infrared spectroscopy newborn

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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term newborns

No interventions assigned to this group

Preterm Newborns (32-37 GA)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Clinically stable
* Spontaneously breathing newborns

Exclusion Criteria

* Congenital heart defects or anomalies of central nervous system
* Prematurity below 32 GA
* Respiratory distress
Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Poznan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Tomasz Szczapa

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Katedra Neonatologii

Poznan, Greater Poland Voivodeship, Poland

Site Status

Countries

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Poland

References

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MacLeod D; Ikeda K; Vacchiano C Simultaneous Comparison of FORE-SIGHT and INVOS Cerebral Oximeters to Jugular Bulb and Arterial Co-Oximetry Measurements in Healthy Volunteers ANESTH ANALG 2009; 108(SCA Suppl);1-104

Reference Type BACKGROUND

Other Identifiers

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04515

Identifier Type: -

Identifier Source: org_study_id