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

• Sponsor: Gorm Greisen (Other)
• Overall Status: Completed
• CT.gov ID: NCT01530360
• Collaborator: Elsass Foundation (Other), Copenhagen Trial Unit, Center for Clinical Intervention Research (Other), Medical University of Graz (Other), Hospices Civils de Lyon (Other), KU Leuven (Other), University College Cork (Other), University of Zurich (Other), University of Milan (Other), Universitair Medisch Centrum Utrecht (Other), University of Witten/Herdecke (Other), Uppsala University (Other), Cambridge University Hospitals NHS Foundation Trust (Other), Hospital Universitario La Paz (Other)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 6
• Patients Per Site Per Month: 1.7

Study Details

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
• Actual Enrollment: 10 participants
• Allocation: N/A
• 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: Sep 1, 2011
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Mar 1, 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 [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 [0-72 hours]

   Expected and unexpected

2. burden of hypo-and hyperoxia [0-72 hours]

   measured as %hours out of the target range (55-85%)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 3 Hours
• 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

Locations

	Site	City	State	Country	Postal Code
1	Department of Neonatology, Rigshospitalet	Copenhagen		Denmark	2100

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Gorm Greisen, MD,DMSci, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Gorm Greisen, professor,head of department, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT01530360
• Other Study ID Numbers: SBP010911
• First Posted: Feb 9, 2012
• Last Update Posted: Dec 10, 2012
• Last Verified: Dec 1, 2012

Study Results

No Results Posted as of Dec 10, 2012