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

September 9, 2013 updated by: Tomasz Szczapa, Poznan University of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Wielkopolskie
      • Poznań, Wielkopolskie, Poland, 60-535
        • Katedra Neonatologii

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 day (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Clinically stable, spontaneously breathing newborns will be included in the study. Enrolled patients will be divided into two groups: 15 term (≥37 weeks GA) and 15 preterm (32-37 weeks GA) newborns. NIRS measurements will be performed on the 1st and 3rd day of life.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
term newborns
Preterm Newborns (32-37 GA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poznan University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

December 10, 2011

First Submitted That Met QC Criteria

December 20, 2011

First Posted (Estimate)

December 21, 2011

Study Record Updates

Last Update Posted (Estimate)

September 10, 2013

Last Update Submitted That Met QC Criteria

September 9, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 04515

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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