Cerebral Oximetry in Newborns - Comparing INVOS 5100 and FORE-SIGHT Cerebral Oximeters

Completed

• Conditions: Near Infrared Spectroscopy

• Registration Number: NCT01665287
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

Regional tissue oxygenation (rStO2) can be monitored by near infrared spectroscopy. The commercial devices FORE-SIGHT (CASMED) and INVOS (COVIDIEN) will be used simultaneously to test for their relative sensitivity for low oxygen levels just after birth on term infants born by elective cesarean section. Reproducibility will be examined by replacements of the sensors six times the next day when the infant is stable and quiet. Neonatal sensors will be used.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-13
• Study First Submitted QC: 2012-08-14
• Study First Posted: 2012-08-15
• Study Completion: 2012-11
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-14
• Last Update Posted: 2013-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Term infants (age more than 37 weeks of gestation)
• Elective cesarean section after an uncomplicated pregnancy

Exclusion criteria:

• Thick hair that makes good measurements difficult/impossible
• Obvious malformations or syndrome
• Complications in relation to the cesarean section
• Depression after birth (APGAR < 8 after 1 minute)

Exclusion Criteria

Not provided

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 or by self-adhesive tape as appropriate.; Curve fitting will be used to describe the rapid increase of oxygenation after birth. Estimated cerebral oxygenation at 3 min (hypoxia) and 10 min (normoxia) will be used to compare the two instruments.

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)

Department of Neonatology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark