Near-infrared Spectroscopy, Transition, Caesarean SectionNCT01771601
Cerebral Oximetry in Newborns - Comparing INVOS 5100c and OxyPrem vs. 1.2
An observational study of Near-infrared Spectroscopy, Transition, Caesarean Section, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 10 minutesHealthy volunteers can take part
- Conditions the study is for
- Near-infrared Spectroscopy, Transition, Caesarean Section
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 minutes
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy term infants born by elective caesarean section at Rigshospitalet, Denmark
Who may be able to join
- Term infants
- Elective caesarean section
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cerebral Oximetry in Newborns - Comparing INVOS 5100c and OxyPrem vs. 1.2's Absolute Values, Sensitivity for Low Oxygen Levels and Reproducibility
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.
- Keywords
- Near-infrared spectroscopy, cerebral oxygenation, term newborn, reproducibility,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Near-infrared spectroscopy sensors | Term infants born by elective Caesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
Secondary outcomes (1)
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Near-infrared Spectroscopy, Transition, Caesarean SectionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- The Augustinus Foundation, Denmark.
- Responsible party
- Principal investigator, Gorm Greisen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771601
- Sponsor's protocol ID
- 090113OXYVOS
- Status last verified
- Sep 2013
- First submitted
- 16 Jan 2013
- Last updated
- 7 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oximetry in Newborns - Comparing INVOS 5100c and OxyPrem vs. 1.2's Absolute Values, Sensitivity for Low Oxygen Levels and Reproducibility
- ClinicalTrials.gov ID
- NCT01771601
- Acronym / sponsor ID
- 090113OXYVOS
- Keywords
- Near-infrared spectroscopy, cerebral oxygenation, term newborn, reproducibility,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- The Augustinus Foundation, Denmark.
- Study start
- Jan 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Near-infrared spectroscopy sensors | – | –Term infants born by elective Caesarean section |
Who may qualify
- Ages
- Up to 10 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy term infants born by elective caesarean section at Rigshospitalet, Denmark
Key inclusion criteria (2 listed)
- Term infants
- Elective caesarean section
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cerebral oxygenation
Time frame: 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.
1 secondary outcome
Reproducibility
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Near-infrared Spectroscopy, Transition, Caesarean Section, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral oxygenation (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2013.