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

Completed

• Conditions: Cerebral Oxygenation

• Registration Number: NCT01496027
• Lead Sponsor: Poznan University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2011-12
• Study First Submitted: 2011-12-10
• Study First Submitted QC: 2011-12-20
• Study First Posted: 2011-12-21
• Study Completion: 2012-04
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-09
• Last Update Posted: 2013-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Clinically stable
• Spontaneously breathing newborns

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Katedra Neonatologii; 🇵🇱 Poznań, Wielkopolskie, Poland