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

Rigshospitalet

Status: Completed

Conditions: Near-infrared Spectroscopy, Transition, Caesarean Section

Study type: Observational

Funder types: Other

Identifiers

NCT01771601

090113OXYVOS

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: Under 10 minutes old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

24 participants in 1 patient group

Near-infrared spectroscopy sensors

Description:

Term infants born by elective Caesarean section