Cerebral OxygenationNCT00926770
Cerebral Near Infrared Spectroscopy During Blood Sampling From a Peripheral Artery Catheter in Preterm Infants
An observational study of Cerebral Oxygenation and Cerebral Blood Flow, run by University of Cologne at 1 site in Germany.
Trial summary
Preterm infants often need peripheral artery catheters for invasive blood pressure recording and to facilitate blood sampling. Near infrared spectroscopy is a method to evaluate cerebral oxygenation and as well as cerebral blood flow. Read more about this study
- Who is it for?
- Ages 1 minute to 7 days
- Conditions the study is for
- Cerebral Oxygenation, Cerebral Blood Flow, Prematurity
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2008to not given
- 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 1 minute to 7 days
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants (Gestational Age <37+0)
Who may be able to join
- Preterm infant (Gestational Age <37+0)
- Peripheral arterial catheter (ulnary or radial artery)
Who cannot join
- Complex organ malformation
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Cologne, NICU
Cologne, North Rhine-Westphalia, 50931
Angela Kribs, MD, 0049221478 ext. 5998, Angela.Kribs@uk-koeln.de
Angela Kribs, MD
About this study
Official title: Measurement of Cerebral Oxygenation With Near Infrared Spectroscopy During Blood Sampling From a Peripheral Artery Catheter in Preterm Infants With Gestational Age <37+0
Preterm infants often need peripheral artery catheters for invasive blood pressure recording and to facilitate blood sampling. Near infrared spectroscopy is a method to evaluate cerebral oxygenation and as well as cerebral blood flow. Sampling procedures with identical sampling volumes are performed at a short (40 seconds) and a long (70 seconds) time intervall while changes of cerebral oxygenation are measured. The investigators hypothesise that slower sampling decrease changes in cerebral blood flow.
- Conditions
- Cerebral Oxygenation, Cerebral Blood Flow, Prematurity
- Medical subject headings
- Premature Birth
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 |
|---|---|---|
| Pretem infants (GG < 37+0) | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral OxygenationStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926770
- Sponsor's protocol ID
- 06-131
- Status last verified
- Jun 2009
- First submitted
- 23 Jun 2009
- Last updated
- 24 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Cerebral Oxygenation With Near Infrared Spectroscopy During Blood Sampling From a Peripheral Artery Catheter in Preterm Infants With Gestational Age <37+0
- ClinicalTrials.gov ID
- NCT00926770
- Acronym / sponsor ID
- 06-131
- Conditions
- Cerebral Oxygenation, Cerebral Blood Flow, Prematurity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Nov 2008
- First posted
- 24 Jun 2009 (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.
Preterm infants often need peripheral artery catheters for invasive blood pressure recording and to facilitate blood sampling. Near infrared spectroscopy is a method to evaluate cerebral oxygenation and as well as cerebral blood flow. Sampling procedures with identical sampling volumes are performed at a short (40 seconds) and a long (70 seconds) time intervall while changes of cerebral oxygenation are measured. The investigators hypothesise that slower sampling decrease changes in cerebral blood flow.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pretem infants (GG < 37+0) | – | – |
Who may qualify
- Ages
- 1 minute to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants (Gestational Age <37+0)
Key inclusion criteria (2 listed)
- Preterm infant (Gestational Age <37+0)
- Peripheral arterial catheter (ulnary or radial artery)
Key exclusion criteria (1 listed)
- Complex organ malformation
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2009.
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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.
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 Cerebral Oxygenation and Cerebral Blood Flow, run by University of Cologne at 1 site in Germany.
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 1 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: status not confirmed, as of the sponsor's last update on 24 Jun 2009. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 24 Jun 2009.