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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01771601

Enrollment

Registered

2013-01-18

Start date

2013-01-31

Completion date

2013-07-31

Last updated

2013-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Near-infrared Spectroscopy, Transition, Caesarean Section

Keywords

Near-infrared spectroscopy, cerebral oxygenation, term newborn, reproducibility,

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 10 Minutes

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Cerebral oxygenation	10 minutes	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.

Secondary

Measure	Time frame	Description
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.

Countries

Denmark

Outcome results