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

This study has been completed.
Sponsor:
Collaborators:
The Elsass Foundation
Copenhagen Trial Unit, Center for Clinical Intervention Research
Medical University of Graz
Hospices Civils de Lyon
Katholieke Universiteit Leuven
University College Cork
University of Zurich
University of Milan
Universitair Medisch Centrum Utrecht
University of Witten/Herdecke
University of Uppsala
University Hospitals NHS Trust Cambridge
La Paz University Hospital Madrid
Information provided by (Responsible Party):
Gorm Greisen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01530360
First received: February 7, 2012
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Premature Infants
Near-infrared Spectroscopy
Oximetry
Device: cerebral oximeter
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safeguarding the Brains of Our Smallest Children - a Pilot Study

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • change of medical management elicited by cerebral oxygenation out of range [ Time Frame: 0-72 hours of life ] [ Designated as safety issue: Yes ]
    Recording of the type of change of management as defined by the treatment guideline


Secondary Outcome Measures:
  • Adverse device effects [ Time Frame: 0-72 hours ] [ Designated as safety issue: Yes ]
    Expected and unexpected

  • burden of hypo-and hyperoxia [ Time Frame: 0-72 hours ] [ Designated as safety issue: No ]
    measured as %hours out of the target range (55-85%)


Enrollment: 10
Study Start Date: September 2011
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 3 Hours
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01530360

Locations
Denmark
Department of Neonatology, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Gorm Greisen
The Elsass Foundation
Copenhagen Trial Unit, Center for Clinical Intervention Research
Medical University of Graz
Hospices Civils de Lyon
Katholieke Universiteit Leuven
University College Cork
University of Zurich
University of Milan
Universitair Medisch Centrum Utrecht
University of Witten/Herdecke
University of Uppsala
University Hospitals NHS Trust Cambridge
La Paz University Hospital Madrid
Investigators
Principal Investigator: Gorm Greisen, MD,DMSci Rigshospitalet, Denmark
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gorm Greisen, professor,head of department, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01530360     History of Changes
Other Study ID Numbers: SBP010911
Study First Received: February 7, 2012
Last Updated: December 7, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

ClinicalTrials.gov processed this record on September 18, 2014