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

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Rigshospitalet

Status

Completed

Conditions

Near Infrared Spectroscopy

Study type

Observational

Funder types

Other

Identifiers

NCT01665287
300712FORVOS

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

Under 2 minutes old

Volunteers

Accepts Healthy Volunteers

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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