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Cerebral Oxygenation to Guide Medical Interventions in Extremely Preterm Infants

Safeguarding the Brains of Our Smallest Children - a Pilot Study

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01530360
Acronym
SafeBoosC-p
Enrollment
10
Registered
2012-02-09
Start date
2011-09-30
Completion date
2012-03-31
Last updated
2012-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Near-infrared Spectroscopy, Oximetry, Premature Infants

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.

Interventions

DEVICEcerebral oximeter

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

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Hours
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

Design outcomes

Primary

MeasureTime frameDescription
change of medical management elicited by cerebral oxygenation out of range0-72 hours of lifeRecording of the type of change of management as defined by the treatment guideline

Secondary

MeasureTime frameDescription
Adverse device effects0-72 hoursExpected and unexpected
burden of hypo-and hyperoxia0-72 hoursmeasured as %hours out of the target range (55-85%)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026