- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01530360
Cerebral Oxygenation to Guide Medical Interventions in Extremely Preterm Infants (SafeBoosC-p)
December 7, 2012 updated by: Gorm Greisen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen, Denmark, 2100
- Department of Neonatology, Rigshospitalet
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 3 hours (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- gestational age at birth less than 28 completed weeks
- cerebral oximeter in place at 3 hours after birth
Exclusion Criteria:
- decision not to provide full life support
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cerebral oximetry + treatment guideline
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
|
INVOS 5100c + SAFB-SM SOMASENSOR NONIN EQUANOX 7600 + sensor model 8000CA
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change of medical management elicited by cerebral oxygenation out of range
Time Frame: 0-72 hours of life
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Recording of the type of change of management as defined by the treatment guideline
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0-72 hours of life
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse device effects
Time Frame: 0-72 hours
|
Expected and unexpected
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0-72 hours
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burden of hypo-and hyperoxia
Time Frame: 0-72 hours
|
measured as %hours out of the target range (55-85%)
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0-72 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gorm Greisen, MD,DMSci, Rigshospitalet, Denmark
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Hyttel-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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
February 7, 2012
First Submitted That Met QC Criteria
February 7, 2012
First Posted (Estimate)
February 9, 2012
Study Record Updates
Last Update Posted (Estimate)
December 10, 2012
Last Update Submitted That Met QC Criteria
December 7, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- SBP010911
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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