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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014