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

Completed

• Conditions: Near-infrared Spectroscopy, Transition, Caesarean Section

• Registration Number: NCT01771601
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-16
• Study First Submitted QC: 2013-01-16
• Study First Posted: 2013-01-18
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-30
• Last Update Posted: 2013-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cerebral oxygenation	10 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Reproducibility	10 minutes	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.

Trial Locations

Locations (1)

Gorm Greisen; 🇩🇰 Copenhagen, Denmark