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

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ClinicalTrials.gov Identifier: NCT01496027
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : September 10, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Cerebral Oxygenation

Study Design

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Comparison of Cerebral Tissue Oxygenation Values in Newborns Measured Simultaneously Using Laser and LED NIRS Oximeters
Study Start Date : December 2011
Primary Completion Date : December 2011
Study Completion Date : April 2012
Groups and Cohorts

term newborns
Preterm Newborns (32-37 GA)

Outcome Measures

Primary Outcome Measures :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Inclusion Criteria:

  • Clinically stable
  • Spontaneously breathing newborns

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496027

Katedra Neonatologii
Poznań, Wielkopolskie, Poland, 60-535
Sponsors and Collaborators
Poznan University of Medical Sciences
More Information

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

Responsible Party: Tomasz Szczapa, M.D., Poznan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01496027     History of Changes
Other Study ID Numbers: 04515
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: September 10, 2013
Last Verified: September 2013

Keywords provided by Tomasz Szczapa, Poznan University of Medical Sciences:
cerebral oxygenation
tissue oximeters
near infrared spectroscopy