Cerebral Tissue Oxygenation Values in Newborns Measured Using Laser and LED NIRS Oximeters
This study has been completed.
Information provided by (Responsible Party):
Tomasz Szczapa, Poznan University of Medical Sciences
First received: December 10, 2011
Last updated: September 9, 2013
Last verified: September 2013
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.
||Observational Model: Case-Only
Time Perspective: Prospective
||A Comparison of Cerebral Tissue Oxygenation Values in Newborns Measured Simultaneously Using Laser and LED NIRS Oximeters
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
There are two FDA-approved near infrared cerebral oximeters:
- FORE-SIGHT- which uses laser light
- 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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2011 (Final data collection date for primary outcome measure)
Preterm Newborns (32-37 GA)
|Ages Eligible for Study:
||up to 1 Day
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- Clinically stable
- Spontaneously breathing newborns
- Congenital heart defects or anomalies of central nervous system
- Prematurity below 32 GA
- Respiratory distress
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01496027
|Poznań, Wielkopolskie, Poland, 60-535 |
Poznan University of Medical Sciences
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
||Tomasz Szczapa, M.D., Poznan University of Medical Sciences
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 10, 2011
||September 9, 2013
||Poland: Ethics Committee
Keywords provided by Poznan University of Medical Sciences:
ClinicalTrials.gov processed this record on June 30, 2015
near infrared spectroscopy