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

Gorm Greisen

Status and phase: Completed; Phase 1

Conditions: Premature Infants; Oximetry; Near-infrared Spectroscopy

Treatments: Device: cerebral oximeter

Study type: Interventional

Funder types: Other

Identifiers

NCT01530360

SBP010911

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: Under 3 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

cerebral oximetry + treatment guideline

Experimental group

Description:

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

Treatment:

Device: cerebral oximeter