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
1 other identifier
observational
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 10, 2011
CompletedFirst Posted
Study publicly available on registry
December 21, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedSeptember 10, 2013
September 1, 2013
Same day
December 10, 2011
September 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of variability and repeatability of the recorded cerebral tissue oxygenation signals between two groups of patients (clinical stable preterm and term newborns)
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.
6 hours
Study Arms (2)
term newborns
Preterm Newborns (32-37 GA)
Eligibility Criteria
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.
You may qualify if:
- Clinically stable
- Spontaneously breathing newborns
You may not qualify if:
- Congenital heart defects or anomalies of central nervous system
- Prematurity below 32 GA
- Respiratory distress
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Katedra Neonatologii
Poznan, Greater Poland Voivodeship, 60-535, Poland
Related Publications (1)
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
BACKGROUND
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
December 10, 2011
First Posted
December 21, 2011
Study Start
December 1, 2011
Primary Completion
December 1, 2011
Study Completion
April 1, 2012
Last Updated
September 10, 2013
Record last verified: 2013-09