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OpenTrials
Completed

NCT Number: NCT01496027

Cerebral Tissue Oxygenation Values in Newborns Measured 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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Key information

Conditions

Cerebral Oxygenation

Age range

1 day–1 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Katedra Neonatologii

Poznan, Greater Poland Voivodeship, 60-535, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinically stable
  • Spontaneously breathing newborns

Exclusion criteria

  • Congenital heart defects or anomalies of central nervous system
  • Prematurity below 32 GA
  • Respiratory distress

Treatment and study plan

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)

    Time frame: 6 hours

    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.

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

A Comparison of Cerebral Tissue Oxygenation Values in Newborns Measured Simultaneously Using Laser and LED NIRS Oximeters

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Dec 21, 2011
Registry last updated
Sep 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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