Cerebral Oximetry in Newborns - Comparing INVOS 5100c and OxyPrem vs. 1.2

Rigshospitalet, Denmark24 enrolled

Overview

Regional tissue oxygenation (cStO2) can be monitored by near infrared spectroscopy. The commercial device INVOS 5100 (COVIDIEN, Mansfield, MA, USA) and the prototype OxyPrem vs. 1.2 (Biomedical Optics Research Laboratory, Zurich, Switzerland) will be used simultaneously to test for their relative sensitivity for low oxygen levels just after birth on term infants born by elective caesarean section. Reproducibility will be examined by replacements of the sensors six times the next day when the infant is stable and quiet. The Adult Somasensor (INVOS) will be used together with the OxyPrem sensor.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Near-infrared Spectroscopy, Transition, Caesarean Section

Eligibility

Sex: ALLMax age: 10 MinutesHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Term infants * Elective caesarean section Exclusion Criteria: * Thick hair that makes good measurements difficult/impossible * obvious malformations or syndromes * Complications in relation to caesarean section * Depression after birth (APGAR \< 8 after 1 minute)

Locations (1)

Gorm Greisen

Copenhagen, Copenhagen, Denmark

Outcomes

Primary Outcomes

Cerebral oxygenation

The sensors of both instruments will be placed on each side of the head. They will be held by hand by self-adhesive tape as appropriate.

Time frame: 10 minutes

Secondary Outcomes

Reproducibility

The sensor will be placed 6 times alternating on each frontoparietal region and held by hand, obtaining 30 seconds of signal for each placement. The placements will be in the same region but not in exactly the same spot. This will be done for both devices.

Time frame: 10 minutes