Cerebral Oxygenation to Guide Medical Interventions in Extremely Preterm Infants

Premature Infants Clinical Trial

— SafeBoosC-p  

Official title:

Safeguarding the Brains of Our Smallest Children - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530360
• Other study ID #: SBP010911
• Status: Completed
• Phase: Phase 1
• First received: February 7, 2012
• Last updated: December 7, 2012
• Start date: September 2011
• Est. completion date: March 2012

Study information

• Verified date: December 2012
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Hours

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Near-infrared Spectroscopy
• Oximetry
• Premature Infants

Intervention

Device:
• cerebral oximeter
INVOS 5100c + SAFB-SM SOMASENSOR NONIN EQUANOX 7600 + sensor model 8000CA

Locations

Country	Name	City	State
Denmark	Department of Neonatology, Rigshospitalet	Copenhagen

Sponsors (14)

Lead Sponsor

Collaborator

Gorm Greisen

Cambridge University Hospitals NHS Foundation Trust, Copenhagen Trial Unit, Center for Clinical Intervention Research, Hospices Civils de Lyon, Hospital Universitario La Paz, Katholieke Universiteit Leuven, Medical University of Graz, The Elsass Foundation, Universitair Medisch Centrum Utrecht, University College Cork, University of Milan, University of Uppsala, University of Witten/Herdecke, University of Zurich

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of medical management elicited by cerebral oxygenation out of range	Recording of the type of change of management as defined by the treatment guideline	0-72 hours of life	Yes
Secondary	Adverse device effects	Expected and unexpected	0-72 hours	Yes
Secondary	burden of hypo-and hyperoxia	measured as %hours out of the target range (55-85%)	0-72 hours	No