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Cerebral Oxygenation to Guide Medical Interventions in Extremely Preterm Infants

NCT ID: NCT01530360

Last Updated: 2012-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Premature Infants Near-infrared Spectroscopy Oximetry

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

cerebral oximeter

Intervention Type DEVICE

INVOS 5100c + SAFB-SM SOMASENSOR NONIN EQUANOX 7600 + sensor model 8000CA

Interventions

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cerebral oximeter

INVOS 5100c + SAFB-SM SOMASENSOR NONIN EQUANOX 7600 + sensor model 8000CA

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

3 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Elsass Foundation

OTHER

Sponsor Role collaborator

Copenhagen Trial Unit, Center for Clinical Intervention Research

OTHER

Sponsor Role collaborator

Medical University of Graz

OTHER

Sponsor Role collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role collaborator

University College Cork

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role collaborator

University of Milan

OTHER

Sponsor Role collaborator

Universitair Medisch Centrum Utrecht

UNKNOWN

Sponsor Role collaborator

University of Witten/Herdecke

OTHER

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role collaborator

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

Hospital Universitario La Paz

OTHER

Sponsor Role collaborator

Gorm Greisen

OTHER

Sponsor Role lead

Responsible Party

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Gorm Greisen

professor,head of department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gorm Greisen, MD,DMSci

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Department of Neonatology, Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 22006900 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23340184 (View on PubMed)

Other Identifiers

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SBP010911

Identifier Type: -

Identifier Source: org_study_id