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

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

      • Copenhagen, Denmark, 2100
        • Department of Neonatology, Rigshospitalet

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

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
Recording of the type of change of management as defined by the treatment guideline
0-72 hours of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse device effects
Time Frame: 0-72 hours
Expected and unexpected
0-72 hours
burden of hypo-and hyperoxia
Time Frame: 0-72 hours
measured as %hours out of the target range (55-85%)
0-72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

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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