Cerebral Oxygenation to Guide Medical Interventions in Extremely Preterm Infants

NCT01530360 — Phase 1, Completed, 10 participants, Gorm Greisen

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Safeguarding the Brains of Our Smallest Children - a Pilot Study

Registry	NCT01530360, acronym SafeBoosC-p
Status	Completed
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, prevention
Enrollment	10 (Actual)
Sponsor	Gorm Greisen (Other); collaborators: 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
Conditions	Premature Infants, Near-infrared Spectroscopy, Oximetry
Interventions	cerebral oximeter (Device)
Dates	start 2011-09-01, primary completion 2011-12-01, completion 2012-03-01, first posted 2012-02-09, last updated 2012-12-10
Locations	1 site in Denmark

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
cerebral oximetry + treatment guideline	Experimental	Device: cerebral oximeter	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

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

+Outcome measures

Primary outcomes

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 outcomes

Adverse device effects [0-72 hours]: Expected and unexpected
burden of hypo-and hyperoxia [0-72 hours]: measured as %hours out of the target range (55-85%)

+Eligibility

Sex: All, ages: any to 3 Hours

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

+Locations (1)

Facility	City	Country	Status
Department of Neonatology, Rigshospitalet	Copenhagen	Denmark

+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. PMID 22006900
Results publication: 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. PMID 23340184

+Investigators

Gorm Greisen, MD,DMSci, Principal investigator, Copenhagen University Hospital, Rigshospitalet

My Notes

Public

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