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

Near Infrared Spectroscopy Clinical Trial

Official title:

Cerebral Oximetry in Newborns - Comparing INVOS 5100 and FORE-SIGHT Cerebral Oximeters Absolute Values, Sensitivity for Low Oxygen Levels and Reproducibility..

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665287
• Other study ID #: 300712FORVOS
• Status: Completed
• Phase: N/A
• First received: August 13, 2012
• Last updated: January 14, 2013
• Start date: August 2012
• Est. completion date: November 2012

Study information

• Verified date: January 2013
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 2 Minutes

Eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Near Infrared Spectroscopy

Locations

Country	Name	City	State
Denmark	Department of Neonatology, Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	The Augustinus Foundation, Denmark.

Country where clinical trial is conducted

Denmark, 

References & Publications (4)

Kratky E, Pichler G, Rehak T, Avian A, Pocivalnik M, Müller W, Urlesberger B. Regional cerebral oxygen saturation in newborn infants in the first 15 min of life after vaginal delivery. Physiol Meas. 2012 Jan;33(1):95-102. doi: 10.1088/0967-3334/33/1/95. — View Citation

Noori S, Wlodaver A, Gottipati V, McCoy M, Schultz D, Escobedo M. Transitional changes in cardiac and cerebral hemodynamics in term neonates at birth. J Pediatr. 2012 Jun;160(6):943-8. doi: 10.1016/j.jpeds.2011.12.008. Epub 2012 Jan 11. — View Citation

Urlesberger B, Grossauer K, Pocivalnik M, Avian A, Müller W, Pichler G. Regional oxygen saturation of the brain and peripheral tissue during birth transition of term infants. J Pediatr. 2010 Nov;157(5):740-4. doi: 10.1016/j.jpeds.2010.05.013. Epub 2010 Jun 17. — View Citation

Urlesberger B, Kratky E, Rehak T, Pocivalnik M, Avian A, Czihak J, Müller W, Pichler G. Regional oxygen saturation of the brain during birth transition of term infants: comparison between elective cesarean and vaginal deliveries. J Pediatr. 2011 Sep;159(3):404-8. doi: 10.1016/j.jpeds.2011.02.030. Epub 2011 Apr 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral oxygenation	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.	10 minutes	No
Secondary	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	No