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

Cerebral Oximetry in Newborns - Comparing INVOS 5100c and OxyPrem vs. 1.2's Absolute Values, Sensitivity for Low Oxygen Levels and Reproducibility

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 Overview

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

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Gorm Greisen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 10 minutes (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy term infants born by elective caesarean section at Rigshospitalet, Denmark

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Near-infrared spectroscopy sensors; Term infants born by elective Caesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 minutes

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: The Augustinus Foundation, Denmark.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: January 16, 2013
• First Submitted That Met QC Criteria: January 16, 2013
• First Posted (ESTIMATE): January 18, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 7, 2013
• Last Update Submitted That Met QC Criteria: September 30, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Near-infrared spectroscopy, cerebral oxygenation, term newborn, reproducibility,
• Other Study ID Numbers: 090113OXYVOS