Premature InfantsPhase 1SafeBoosC-pNCT01530360
Cerebral Oxygenation to Guide Medical Interventions in Extremely Preterm Infants
A Phase 1 study testing cerebral oximeter in people with Premature Infants and Near-infrared Spectroscopy, run by Gorm Greisen at 1 site in Denmark.
Trial summary
Regional tissue oxygenation (rStO2) can be monitored by near-infrared spectroscopy. The investigators planned a SafeBoosC phase II trial to test if a reduction of the burden of hyper- and hypoxia can be accomplished during the first three days of life in infants born before 28 completed weeks of gestation. Read more about this study
- Who is it for?
- Ages Up to 3 hours
- Conditions the study is for
- Premature Infants, Near-infrared Spectroscopy, Oximetry
- What is being tested?
- cerebral oximeter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2011to Mar 2012
- Phase
- Phase 1
- 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 3 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- gestational age at birth less than 28 completed weeks
- cerebral oximeter in place at 3 hours after birth
Who cannot join
- decision not to provide full life support
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safeguarding the Brains of Our Smallest Children - a Pilot Study
Regional tissue oxygenation (rStO2) can be monitored by near-infrared spectroscopy. The investigators planned a SafeBoosC phase II trial to test if a reduction of the burden of hyper- and hypoxia can be accomplished during the first three days of life in infants born before 28 completed weeks of gestation. The investigators developed a treatment guideline and a randomised trial design to evaluate if cerebral rStO2 spent out of range in %hours can be reduced by 50%. The present trial is a non-randomised pilot study of the intervention in 10 infants.
- Conditions
- Premature Infants, Near-infrared Spectroscopy, Oximetry
- Being tested
- cerebral oximeter
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cerebral oximeterDevice
INVOS 5100c + SAFB-SM SOMASENSOR NONIN EQUANOX 7600 + sensor model 8000CA
| Study group | Role | What they receive |
|---|---|---|
| cerebral oximetry + treatment guideline | Experimental | Cerebral oximetry applied as soon as possible after birth and continued until 72 hours of life Clinical staff administer the routine medical management according to local practice as well as respond to out-of-range values with the help of the treatment guideline Receives: Device: cerebral oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of medical management elicited by cerebral oxygenation out of range
Recording of the type of change of management as defined by the treatment guideline
Measured: 0-72 hours of life
Secondary outcomes (2)
Adverse device effects
Expected and unexpected
Measured: 0-72 hours
burden of hypo-and hyperoxia
measured as %hours out of the target range (55-85%)
Measured: 0-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Premature InfantsStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gorm Greisen
- Sponsor type
- University, hospital or other
- Collaborators
- Elsass Foundation, Copenhagen Trial Unit, Center for Clinical Intervention Research, Medical University of Graz, Hospices Civils de Lyon, KU Leuven, University College Cork, University of Zurich, University of Milan, Universitair Medisch Centrum Utrecht, University of Witten/Herdecke, Uppsala University, Cambridge University Hospitals NHS Foundation Trust, Hospital Universitario La Paz
- Responsible party
- Sponsor-investigator, Gorm Greisen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Gorm Greisen, MD,DMSci, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530360
- Sponsor's protocol ID
- SBP010911
- Acronym
- SafeBoosC-p
- Status last verified
- Dec 2012
- First submitted
- 7 Feb 2012
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Greisen G, Leung T, Wolf M. Has the time come to use near-infrared spectroscopy as a routine clinical tool in preterm infants undergoing intensive care? Philos Trans A Math Phys Eng Sci. 2011 Nov 28;369(1955):4440-51. doi: 10.1098/rsta.2011.0261.
PubMed 22006900Hyttel-Sorensen S, Austin T, van Bel F, Benders M, Claris O, Dempsey EM, Fumagalli M, Gluud C, Hagmann C, Hellstrom-Westas L, Lemmers P, Naulaers G, van Oeveren W, Pellicer A, Pichler G, Roll C, Stoy LS, Wolf M, Greisen G. Clinical use of cerebral oximetry in extremely preterm infants is feasible. Dan Med J. 2013 Jan;60(1):A4533.
PubMed 23340184
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safeguarding the Brains of Our Smallest Children - a Pilot Study
- ClinicalTrials.gov ID
- NCT01530360
- Acronym / sponsor ID
- SafeBoosC-p / SBP010911
- Conditions
- Premature Infants, Near-infrared Spectroscopy, Oximetry
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Gorm GreisenUniversity, hospital or other
- Collaborators
- Elsass Foundation, Copenhagen Trial Unit, Center for Clinical Intervention Research, Medical University of Graz, Hospices Civils de Lyon, KU Leuven, University College Cork, University of Zurich, University of Milan, Universitair Medisch Centrum Utrecht, University of Witten/Herdecke, Uppsala University, Cambridge University Hospitals NHS Foundation Trust, Hospital Universitario La Paz
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 9 Feb 2012 (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.
Regional tissue oxygenation (rStO2) can be monitored by near-infrared spectroscopy. The investigators planned a SafeBoosC phase II trial to test if a reduction of the burden of hyper- and hypoxia can be accomplished during the first three days of life in infants born before 28 completed weeks of gestation. The investigators developed a treatment guideline and a randomised trial design to evaluate if cerebral rStO2 spent out of range in %hours can be reduced by 50%. The present trial is a non-randomised pilot study of the intervention in 10 infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cerebral oximetry + treatment guideline | Experimental | Device: cerebral oximeterCerebral oximetry applied as soon as possible after birth and continued until 72 hours of life Clinical staff administer the routine medical management according to local practice as well as respond to out-of-range values with the help of the treatment guideline |
Who may qualify
- Ages
- Up to 3 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- gestational age at birth less than 28 completed weeks
- cerebral oximeter in place at 3 hours after birth
Key exclusion criteria (1 listed)
- decision not to provide full life support
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 |
|---|---|---|
| cerebral oximeterINVOS 5100c + SAFB-SM SOMASENSOR NONIN EQUANOX 7600 + sensor model 8000CA | Device | cerebral oximetry + treatment guideline |
Primary outcome
change of medical management elicited by cerebral oxygenation out of range
Time frame: 0-72 hours of life
Recording of the type of change of management as defined by the treatment guideline
2 secondary outcomes
Adverse device effects
Time frame: 0-72 hours
burden of hypo-and hyperoxia
Time frame: 0-72 hours
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 Dec 2012.
- Background: PubMed 22006900Greisen G, Leung T, Wolf M. Has the time come to use near-infrared spectroscopy as a routine clinical tool in preterm infants undergoing intensive care? Philos Trans A Math Phys Eng Sci. 2011 Nov 28;369(1955):4440-51. doi: 10.1098/rsta.2011.0261.
- Derived from this study: PubMed 23340184Hyttel-Sorensen S, Austin T, van Bel F, Benders M, Claris O, Dempsey EM, Fumagalli M, Gluud C, Hagmann C, Hellstrom-Westas L, Lemmers P, Naulaers G, van Oeveren W, Pellicer A, Pichler G, Roll C, Stoy LS, Wolf M, Greisen G. Clinical use of cerebral oximetry in extremely preterm infants is feasible. Dan Med J. 2013 Jan;60(1):A4533.
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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.
Gorm Greisen, MD,DMSci principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cerebral oximeter in people with Premature Infants and Near-infrared Spectroscopy, run by Gorm Greisen at 1 site in Denmark.
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 1 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 Dec 2012. 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 Denmark. 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 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.
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?
change of medical management elicited by cerebral oxygenation out of range (time frame: 0-72 hours of life). 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 NCT01530360, which also lists 2 linked publications.
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 Dec 2012.