Cerebral Tissue Oxygenation Values in Newborns Measured Using Laser and LED NIRS Oximeters
This study is currently recruiting participants.
Verified April 2012 by Poznan University of Medical Sciences
Sponsor:
Poznan University of Medical Sciences
Information provided by (Responsible Party):
Tomasz Szczapa, Poznan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01496027
First received: December 10, 2011
Last updated: April 24, 2012
Last verified: April 2012
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Purpose
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 |
|---|
|
Cerebral Oxygenation |
| Study Type: | Observational |
| Study Design: | 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 |
Further study details as provided by Poznan University of Medical Sciences:
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.
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | April 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| term newborns |
| Preterm Newborns (32-37 GA) |
Eligibility| Ages Eligible for Study: | up to 1 Day |
| Genders Eligible for Study: | Both |
| 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.
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496027
Contacts
| Contact: Tomasz Szczapa, MD | +48-607576-457 | tszczapa@ump.edu.pl |
Locations
| Poland | |
| Katedra Neonatologii | Recruiting |
| Poznań, Wielkopolskie, Poland, 60-535 | |
| Contact: Tomasz Szczapa, MD +48-607-576-457 tszczapa@ump.edu.pl | |
| Sub-Investigator: Łukasz Karpiński, general practitioner | |
| Sub-Investigator: Karolina Chojnacka, MD | |
| Sub-Investigator: Aleksandra Adamczak, general practiotioner | |
| Sub-Investigator: Aleksandra Jopek, MD | |
Sponsors and Collaborators
Poznan University of Medical Sciences
More Information
No publications provided
| Responsible Party: | Tomasz Szczapa, M.D., Poznan University of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01496027 History of Changes |
| Other Study ID Numbers: | 04515 |
| Study First Received: | December 10, 2011 |
| Last Updated: | April 24, 2012 |
| Health Authority: | Poland: Ethics Committee |
Keywords provided by Poznan University of Medical Sciences:
|
cerebral oxygenation NIRS tissue oximeters near infrared spectroscopy newborn |
ClinicalTrials.gov processed this record on May 16, 2013