A Comparison of Cerebral Tissue Oxygenation Values in Newborns Measured Simultaneously Using Laser and LED NIRS Oximeters

Poznan University of Medical Sciences1 site in 1 country30 target enrollmentDecember 2011

ConditionsCerebral Oxygenation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cerebral Oxygenation
Sponsor: Poznan University of Medical Sciences
Enrollment: 30
Locations: 1
Primary Endpoint: Comparison of variability and repeatability of the recorded cerebral tissue oxygenation signals between two groups of patients (clinical stable preterm and term newborns)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

April 2012

Last Updated

12 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Poznan University of Medical Sciences

Responsible Party

Principal Investigator

Tomasz Szczapa

M.D.

Poznan University of Medical Sciences

Eligibility Criteria

Inclusion Criteria

•Clinically stable
•Spontaneously breathing newborns

Exclusion Criteria

•Congenital heart defects or anomalies of central nervous system
•Prematurity below 32 GA
•Respiratory distress

Outcomes

Primary Outcomes

Comparison of variability and repeatability of the recorded cerebral tissue oxygenation signals between two groups of patients (clinical stable preterm and term newborns)

Time Frame: 6 hours

There are two FDA-approved near infrared cerebral oximeters: 1. FORE-SIGHT- which uses laser light 2. INVOS 5100- which uses light emmiting diode. Measurements in adult patients have showed that FORE-SIGHT provides more stable signal. Purpose of our study is to compare these two devices in newborn patients.