Cerebral Oxygenation to Guide Medical Interventions in Extremely Preterm Infants

Gorm Greisen10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Premature Infants Near-infrared Spectroscopy Oximetry

Interventions

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

Eligibility

Sex: ALLMax age: 3 Hours

Medical Language ↔ Plain English

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)

Department of Neonatology, Rigshospitalet

Copenhagen, Denmark

Outcomes

Primary Outcomes

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

Time frame: 0-72 hours of life

Secondary Outcomes

Adverse device effects

Expected and unexpected

Time frame: 0-72 hours

burden of hypo-and hyperoxia

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

Time frame: 0-72 hours

Data from ClinicalTrials.gov

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