Oxygen SaturationPhase 1/2COSGODNCT02017691
Cerebral Oxygenation to Guide Supplemental Oxygen
A Phase 1/2 study testing Near Infrared Spectroscopy and Pulse-oximetry in people with Oxygen Saturation, run by Medical University of Graz at 2 sites in 2 countries.
Trial summary
Objective: Objective of this pilot feasibility study is to monitor crSO2 using NIRS INVOS 5100 (Somanetics, USA) in addition to SpO2 monitoring to guide supplemental oxygen delivery and respiratory support based on both measurements in preterm neonates during the first 15 minutes after birth. Read more about this study
- Who is it for?
- Ages Up to 15 minutes
- Conditions the study is for
- Oxygen Saturation
- What is being tested?
- Near Infrared Spectroscopy and Pulse-oximetry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2013to Apr 2015
- Phase
- Phase 1/2
- 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 Up to 15 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm neonate <34+0 weeks after caesarean section
- Decision to conduct full life support
- Written informed consent
Who cannot join
- No decision to conduct full life support
- No written informed consent
- Congenital malformation
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Austria1 site
Department of Pediatrics, Medical University of Graz
Graz, Styria, 8036
Canada1 site
Department of Pediatrics, Royal Alexandra Hospital
Edmonton, Alberta
About this study
Official title: Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition After Birth (COSGOD) - a Prospective Two-centre Randomized Controlled Pilot Feasibility Study
Objective: Objective of this pilot feasibility study is to monitor crSO2 using NIRS INVOS 5100 (Somanetics, USA) in addition to SpO2 monitoring to guide supplemental oxygen delivery and respiratory support based on both measurements in preterm neonates during the first 15 minutes after birth.
Patients: Preterm neonates <34+0 weeks of gestation born via caesarean section and/or who require respiratory support will be eligible for the study.
Read more
Design: A prospective two-centre randomized controlled pilot feasibility study
Methods: Study group: Pulse oximetry will be used to measure SpO2 and heart rate as routine non-invasive monitoring in the first minutes of resuscitation. In addition during the first 15 minutes NIRS measurements will be recorded. crSO2 measurements in addition SpO2 measurements will be used to guide supplemental oxygen support and respiratory support during the first 15 minutes after birth. Control group: Only SpO2 measurements will be used to guide supplemental oxygen support and respiratory support during the first 15 minutes after birth.
Hypothesis: Supplemental oxygen support and respiratory support guided by crSO2 and SpO2 measurements will reduce the time in % minutes of crSO2 <10th or >90th centile in preterm neonates during the first 15 minutes after birth
Outcome Parameter: Primary outcome parameter will be duration in % minute of crSO2 <10th or >90th centile.
- Conditions
- Oxygen Saturation
- Being tested
- Near Infrared Spectroscopy, Pulse-oximetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infrared SpectroscopyDevice
If crSO2 is <10th centile, CPAP via face mask will be started or oxygen support will be increased depending SpO2, on the infants breathing efforts and the heart rate. If crSO2 remains stable >10th centile, or if crSO2 is > 90th centile CPAP via face mask will be stopped or FiO2 will be reduced depending on SpO2, the infants breathing efforts and the heart rate.
Pulse-oximetryDevice
If SpO2 remains <10th centile, respiratory support via face mask will be started or FiO2 will be increased depending on the infants breathing efforts and the heart rate. If SpO2 remains stable or if SpO2 is >90th centile respiratory support via face mask will be stopped or FiO2 will be reduced depending on the infants breathing efforts and the heart rate.
| Study group | Role | What they receive |
|---|---|---|
| Near Infrared Spectroscopy | Experimental | crSO2 measurements in addition SpO2 measurements will be visible to guide supplemental oxygen support and respiratory support according predefined interventions depending on the infants breathing efforts and the heart rate during the first 15 minutes after birth Receives: Device: Near Infrared Spectroscopy |
| Pulse-oximetry | Other | Only SpO2 measurements will be visible to guide supplemental oxygen support and respiratory support according predefined interventions depending on the infants breathing efforts and the heart rate during the first 15 minutes after birth Receives: Device: Pulse-oximetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral tissue oxygen saturation (crSO2)
Duration in % minute of crSO2 <10th or >90th centile
Measured: 15 minutes
Secondary outcomes (3)
Mortality
Rate of mortality
Measured: 16 weeks
Cerebral injury
Cerebral injury assessed by sonography
Measured: 16 weeks
Neurodevelopmental outcome
General movements
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionFeb 2015
- Study completionApr 2015
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 Oxygen SaturationStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pichler Gerhard, MD., Medical University of Graz
- Investigators
- Gerhard Pichler, MD, Principal investigator, Dep. of Pediatrics, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017691
- Sponsor's protocol ID
- 25-295
- Acronym
- COSGOD
- Status last verified
- Apr 2015
- First submitted
- 28 Nov 2013
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Pichler G, Urlesberger B, Baik N, Schwaberger B, Binder-Heschl C, Avian A, Pansy J, Cheung PY, Schmolzer GM. Cerebral Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates for the Immediate Transition after Birth: A 2-Center Randomized Controlled Pilot Feasibility Trial. J Pediatr. 2016 Mar;170:73-8.e1-4. doi: 10.1016/j.jpeds.2015.11.053. Epub 2015 Dec 30.
PubMed 26743498
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition After Birth (COSGOD) - a Prospective Two-centre Randomized Controlled Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT02017691
- Acronym / sponsor ID
- COSGOD / 25-295
- Conditions
- Oxygen Saturation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 23 Dec 2013 (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.
Objective: Objective of this pilot feasibility study is to monitor crSO2 using NIRS INVOS 5100 (Somanetics, USA) in addition to SpO2 monitoring to guide supplemental oxygen delivery and respiratory support based on both measurements in preterm neonates during the first 15 minutes after birth.
Patients: Preterm neonates <34+0 weeks of gestation born via caesarean section and/or who require respiratory support will be eligible for the study.
Design: A prospective two-centre randomized controlled pilot feasibility study
Methods: Study group: Pulse oximetry will be used to measure SpO2 and heart rate as routine non-invasive monitoring in the first minutes of resuscitation. In addition during the first 15 minutes NIRS measurements will be recorded. crSO2 measurements in addition SpO2 measurements will be used to guide supplemental oxygen support and respiratory support during the first 15 minutes after birth. Control group: Only SpO2 measurements will be used to guide supplemental oxygen support and respiratory support during the first 15 minutes after birth.
Hypothesis: Supplemental oxygen support and respiratory support guided by crSO2 and SpO2 measurements will reduce the time in % minutes of crSO2 <10th or >90th centile in preterm neonates during the first 15 minutes after birth
Outcome Parameter: Primary outcome parameter will be duration in % minute of crSO2 <10th or >90th centile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Near Infrared Spectroscopy | Experimental | Device: Near Infrared SpectroscopycrSO2 measurements in addition SpO2 measurements will be visible to guide supplemental oxygen support and respiratory support according predefined interventions depending on the infants breathing efforts and the heart rate during the first 15 minutes after birth |
| Pulse-oximetry | Other | Device: Pulse-oximetryOnly SpO2 measurements will be visible to guide supplemental oxygen support and respiratory support according predefined interventions depending on the infants breathing efforts and the heart rate during the first 15 minutes after birth |
Who may qualify
- Ages
- Up to 15 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm neonate <34+0 weeks after caesarean section
- Decision to conduct full life support
- Written informed consent
Key exclusion criteria (3 listed)
- No decision to conduct full life support
- No written informed consent
- Congenital malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near Infrared SpectroscopyIf crSO2 is <10th centile, CPAP via face mask will be started or oxygen support will be increased depending SpO2, on the infants breathing efforts and the heart rate. If crSO2 remains stable >10th centile, or if crSO2 is > 90th centile CPAP via face mask will be stopped or FiO2 will be reduced depending on SpO2, the infants breathing efforts and the heart rate. | Device | Near Infrared Spectroscopy |
| Pulse-oximetryIf SpO2 remains <10th centile, respiratory support via face mask will be started or FiO2 will be increased depending on the infants breathing efforts and the heart rate. If SpO2 remains stable or if SpO2 is >90th centile respiratory support via face mask will be stopped or FiO2 will be reduced depending on the infants breathing efforts and the heart rate. | Device | Pulse-oximetry |
Primary outcome
Cerebral tissue oxygen saturation (crSO2)
Time frame: 15 minutes
Duration in % minute of crSO2 <10th or >90th centile
3 secondary outcomes
Mortality
Time frame: 16 weeks
Cerebral injury
Time frame: 16 weeks
Neurodevelopmental outcome
Time frame: 16 weeks
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 17 Apr 2015.
- Derived from this study: PubMed 26743498Pichler G, Urlesberger B, Baik N, Schwaberger B, Binder-Heschl C, Avian A, Pansy J, Cheung PY, Schmolzer GM. Cerebral Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates for the Immediate Transition after Birth: A 2-Center Randomized Controlled Pilot Feasibility Trial. J Pediatr. 2016 Mar;170:73-8.e1-4. doi: 10.1016/j.jpeds.2015.11.053. Epub 2015 Dec 30.
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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.
Gerhard Pichler, MD principal investigator
Dep. of Pediatrics, Medical University of Graz
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Near Infrared Spectroscopy and Pulse-oximetry in people with Oxygen Saturation, run by Medical University of Graz at 2 sites in 2 countries.
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 3 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 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Canada. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cerebral tissue oxygen saturation (crSO2) (time frame: 15 minutes). 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 NCT02017691, 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 17 Apr 2015.