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

NCT01665287 | Completed

• 1 other identifier: 300712FORVOS
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Near Infrared Spectroscopy

Keywords

Cerebral Oximetry; Near infrared spectroscopy; Fullterm; Infant

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Reproducibility

  10 minutes

Eligibility Criteria

• Age: Up to 2 Minutes
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Term infants born by elective cesarian section.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• The Augustinus Foundation, Denmark.: collaborator

Study Sites (1)

Department of Neonatology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (4)

• 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.

  PMID: 22244465 BACKGROUND

• Kratky E, Pichler G, Rehak T, Avian A, Pocivalnik M, Muller 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.

  PMID: 22173332 BACKGROUND

• Urlesberger B, Kratky E, Rehak T, Pocivalnik M, Avian A, Czihak J, Muller 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.

  PMID: 21481417 BACKGROUND

• Urlesberger B, Grossauer K, Pocivalnik M, Avian A, Muller 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.

  PMID: 20955848 BACKGROUND

Study Officials

• Gorm Greisen, Professor

  Not relevant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: August 13, 2012
• First Posted: August 15, 2012
• Study Start: August 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 15, 2013

Record last verified: 2013-01

Locations

DK (1)