Cerebral Oxygenation to Guide Medical Interventions in Extremely Preterm Infants

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.

Conditions

• Premature Infants
• Near-infrared Spectroscopy
• Oximetry

Interventions

DEVICE

cerebral oximeter

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

Sponsors & Collaborators

• Elsass Foundation

  collaborator OTHER

• Copenhagen Trial Unit, Center for Clinical Intervention Research

  collaborator OTHER

• Medical University of Graz

  collaborator OTHER

• Hospices Civils de Lyon

  collaborator OTHER

• KU Leuven

  collaborator OTHER

• University College Cork

  collaborator OTHER

• University of Zurich

  collaborator OTHER

• University of Milan

  collaborator OTHER

• Universitair Medisch Centrum Utrecht

  collaborator UNKNOWN

• University of Witten/Herdecke

  collaborator OTHER

• Uppsala University

  collaborator OTHER

• Cambridge University Hospitals NHS Foundation Trust

  collaborator OTHER

• Hospital Universitario La Paz

  collaborator OTHER

• Gorm Greisen

  lead OTHER

Principal Investigators

• Gorm Greisen, MD,DMSci · Rigshospitalet, Denmark

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

3 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-09-30

Primary Completion

2011-12-31

Completion

2012-03-31

Countries

• Denmark

Study Locations