NCT01771601

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

October 7, 2013

Status Verified

September 1, 2013

Enrollment Period

6 months

First QC Date

January 16, 2013

Last Update Submit

September 30, 2013

Conditions

Near-infrared Spectroscopy, Transition, Caesarean Section

Keywords

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

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 by self-adhesive tape as appropriate.

    10 minutes

Secondary Outcomes (1)

  • Reproducibility

    10 minutes

Study Arms (1)

Near-infrared spectroscopy sensors

Term infants born by elective Caesarean section

Eligibility Criteria

AgeUp to 10 Minutes
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Healthy term infants born by elective caesarean section at Rigshospitalet, Denmark

You may qualify if:

  • Term infants
  • Elective caesarean section

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gorm Greisen

Copenhagen, Copenhagen, 2100, Denmark

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 16, 2013

First Posted

January 18, 2013

Study Start

January 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

October 7, 2013

Record last verified: 2013-09

Locations

DK(1)