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

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ClinicalTrials.gov Identifier: NCT01530360
Recruitment Status : Completed
First Posted : February 9, 2012
Last Update Posted : December 10, 2012
Information provided by (Responsible Party):

Study Description
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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Primary Completion Date : December 2011
Study Completion Date : March 2012
Arms and Interventions

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

Outcome Measures

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%)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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

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
Cambridge University Hospitals NHS Foundation Trust
Hospital Universitario La Paz
Principal Investigator: Gorm Greisen, MD,DMSci Rigshospitalet, Denmark