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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01496027

Enrollment

Registered

2011-12-21

Start date

2011-12-31

Completion date

2012-04-30

Last updated

2013-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Oxygenation

Keywords

cerebral oxygenation, NIRS, tissue oximeters, near infrared spectroscopy, newborn

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 1 Days

Healthy volunteers

Yes

Inclusion criteria

* Clinically stable * Spontaneously breathing newborns

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Comparison of variability and repeatability of the recorded cerebral tissue oxygenation signals between two groups of patients (clinical stable preterm and term newborns)	6 hours	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.

Countries

Poland

Outcome results