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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tomasz Szczapa, Poznan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01496027
First received: December 10, 2011
Last updated: September 9, 2013
Last verified: September 2013

December 10, 2011
September 9, 2013
December 2011
December 2011   (final data collection date for primary outcome measure)
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:

  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.

Same as current
Complete list of historical versions of study NCT01496027 on ClinicalTrials.gov Archive Site
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Cerebral Tissue Oxygenation Values in Newborns Measured Using Laser and LED NIRS Oximeters
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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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.

Cerebral Oxygenation
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  • term newborns
  • Preterm Newborns (32-37 GA)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinically stable
  • Spontaneously breathing newborns

Exclusion Criteria:

  • Congenital heart defects or anomalies of central nervous system
  • Prematurity below 32 GA
  • Respiratory distress
Both
up to 1 Day
Yes
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01496027
04515
No
Tomasz Szczapa, Poznan University of Medical Sciences
Poznan University of Medical Sciences
Not Provided
Not Provided
Poznan University of Medical Sciences
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP