Cerebral OxygenationNCT01496027
Cerebral Tissue Oxygenation Values in Newborns Measured Using Laser and LED NIRS Oximeters
An observational study of Cerebral Oxygenation, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 to 1 dayHealthy volunteers can take part
- Conditions the study is for
- Cerebral Oxygenation
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- Dec 2011to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 to 1 day
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Clinically stable
- Spontaneously breathing newborns
Who cannot join
- Congenital heart defects or anomalies of central nervous system
- Prematurity below 32 GA
- Respiratory distress
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Cerebral Tissue Oxygenation Values in Newborns Measured Simultaneously 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.
- Conditions
- Cerebral Oxygenation
- Keywords
- cerebral oxygenation, NIRS, tissue oximeters, near infrared spectroscopy, newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| term newborns | Not described | |
| Preterm Newborns (32-37 GA) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral OxygenationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Szczapa, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496027
- Sponsor's protocol ID
- 04515
- Status last verified
- Sep 2013
- First submitted
- 10 Dec 2011
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Cerebral Tissue Oxygenation Values in Newborns Measured Simultaneously Using Laser and LED NIRS Oximeters
- ClinicalTrials.gov ID
- NCT01496027
- Acronym / sponsor ID
- 04515
- Conditions
- Cerebral Oxygenation
- Keywords
- cerebral oxygenation, NIRS, tissue oximeters, near infrared spectroscopy, newborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 21 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| term newborns | – | – |
| Preterm Newborns (32-37 GA) | – | – |
Who may qualify
- Ages
- 1 to 1 day
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Clinically stable
- Spontaneously breathing newborns
Key exclusion criteria (3 listed)
- Congenital heart defects or anomalies of central nervous system
- Prematurity below 32 GA
- Respiratory distress
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
- BackgroundMacLeod 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Oxygenation, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01496027, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2013.