Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cerebral Oxygenation to Guide Medical Interventions in Extremely Preterm Infants (SafeBoosC-p)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01530360
Recruitment Status : Completed
First Posted : February 9, 2012
Last Update Posted : December 10, 2012
Sponsor:
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
Information provided by (Responsible Party):
Gorm Greisen, Rigshospitalet, Denmark

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Premature Infants Near-infrared Spectroscopy Oximetry Device: cerebral oximeter Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safeguarding the Brains of Our Smallest Children - a Pilot Study
Study Start Date : September 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : March 2012

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
Device: cerebral oximeter
INVOS 5100c + SAFB-SM SOMASENSOR NONIN EQUANOX 7600 + sensor model 8000CA




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Adverse device effects [ Time Frame: 0-72 hours ]
    Expected and unexpected

  2. burden of hypo-and hyperoxia [ Time Frame: 0-72 hours ]
    measured as %hours out of the target range (55-85%)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 3 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530360


Locations
Layout table for location information
Denmark
Department of Neonatology, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Gorm Greisen
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
Investigators
Layout table for investigator information
Principal Investigator: Gorm Greisen, MD,DMSci Rigshospitalet, Denmark
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Gorm Greisen, professor,head of department, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01530360    
Other Study ID Numbers: SBP010911
First Posted: February 9, 2012    Key Record Dates
Last Update Posted: December 10, 2012
Last Verified: December 2012