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
  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:

    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.



Enrollment: 30
Study Start Date: December 2011
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

Locations
Poland
Katedra Neonatologii
Poznań, Wielkopolskie, Poland, 60-535
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: September 9, 2013
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 April 15, 2014