Intracranial HemorrhageNIRSNCT00795119
A Trial to Determine the Efficacy of Near Infrared Spectroscopy to Detect Intracranial Hemorrhage in Children
A study testing Near Infrared Spectroscopy (NIRS) in people with Intracranial Hemorrhage, run by IWK Health Centre at 1 site in Canada.
Trial summary
To diagnose bleeding inside the head, children need to have a CT Scan or MRI of their heads. Not all doctors order these though, especially when there is no history of injury or when children don't look too sick. Unfortunately, this means that some children's bleeding doesn't get diagnosed as early as it could. Read more about this study
- Who is it for?
- Ages Up to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Intracranial Hemorrhage
- What is being tested?
- Near Infrared Spectroscopy (NIRS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2007to Feb 2009
- Phase
- Interventional
- 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 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children under 3 years of age who undergo a CT of the head or MRI of the head.
Who cannot join
- Lack of parental consent
- Neurosurgical intervention between CT/MRI and NIRS scanning.
- Scalp hematoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Assessment of the Reliability of Near Infrared Spectroscopy for the Detection of Intracranial Hemorrhage in Young Children
To diagnose bleeding inside the head, children need to have a CT Scan or MRI of their heads. Not all doctors order these though, especially when there is no history of injury or when children don't look too sick. Unfortunately, this means that some children's bleeding doesn't get diagnosed as early as it could. This study wants to find a way to detect bleeding inside the head without using a CT scan or MRI.
- Conditions
- Intracranial Hemorrhage
- Being tested
- Near Infrared Spectroscopy (NIRS)
- Keywords
- Near Infrared Spectroscopy, Diagnosis, Children
- Medical subject headings
- Intracranial Hemorrhages, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infrared Spectroscopy (NIRS)Device
NIRS of the head is undertaken at the time of CT or MRI examination
| Study group | Role | What they receive |
|---|---|---|
| NIRS | Experimental | Children who undergo NIRS Receives: Device: Near Infrared Spectroscopy (NIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of NIRS
Measured: Study conclusion
Secondary outcomes (1)
specificity of NIRS, positive/negative predictive value
Measured: Study conclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startSep 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HemorrhageStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Investigators
- Steven Bellemare, MD, Principal investigator, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795119
- Sponsor's protocol ID
- IWK3748
- Acronym
- NIRS
- Status last verified
- Nov 2008
- First submitted
- 19 Nov 2008
- Last updated
- 3 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Assessment of the Reliability of Near Infrared Spectroscopy for the Detection of Intracranial Hemorrhage in Young Children
- ClinicalTrials.gov ID
- NCT00795119
- Acronym / sponsor ID
- NIRS / IWK3748
- Conditions
- Intracranial Hemorrhage
- Keywords
- Near Infrared Spectroscopy, Diagnosis, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 21 Nov 2008 (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.
To diagnose bleeding inside the head, children need to have a CT Scan or MRI of their heads. Not all doctors order these though, especially when there is no history of injury or when children don't look too sick. Unfortunately, this means that some children's bleeding doesn't get diagnosed as early as it could. This study wants to find a way to detect bleeding inside the head without using a CT scan or MRI.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIRS | Experimental | Device: Near Infrared Spectroscopy (NIRS)Children who undergo NIRS |
Who may qualify
- Ages
- Up to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children under 3 years of age who undergo a CT of the head or MRI of the head.
Key exclusion criteria (3 listed)
- Lack of parental consent
- Neurosurgical intervention between CT/MRI and NIRS scanning.
- Scalp hematoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near Infrared Spectroscopy (NIRS)NIRS of the head is undertaken at the time of CT or MRI examination | Device | NIRS |
Primary outcome
Sensitivity of NIRS
Time frame: Study conclusion
1 secondary outcome
specificity of NIRS, positive/negative predictive value
Time frame: Study conclusion
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 3 Apr 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.
Steven Bellemare, MD principal investigator
IWK Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Near Infrared Spectroscopy (NIRS) in people with Intracranial Hemorrhage, run by IWK Health Centre at 1 site in Canada.
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 1 inclusion and 3 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 3 Apr 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 Canada. 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?
Sensitivity of NIRS (time frame: Study conclusion). 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 3 Apr 2009.