Back to resultsA Trial to Determine the Efficacy of Near Infrared Spectroscopy to Detect Intracranial Hemorrhage in Children (NIRS)
Primary Purpose
Intracranial Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Near Infrared Spectroscopy (NIRS)
Sponsored by
About this trial
This is an interventional screening trial for Intracranial Hemorrhage focused on measuring Near Infrared Spectroscopy, Diagnosis, Children
Eligibility Criteria
Inclusion Criteria:
- All children under 3 years of age who undergo a CT of the head or MRI of the head.
Exclusion Criteria:
- Lack of parental consent
- Neurosurgical intervention between CT/MRI and NIRS scanning.
- Scalp hematoma
Sites / Locations
- IWK Health Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NIRS
Arm Description
Children who undergo NIRS
Outcomes
Primary Outcome Measures
Sensitivity of NIRS
Secondary Outcome Measures
specificity of NIRS, positive/negative predictive value
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00795119
Brief Title
A Trial to Determine the Efficacy of Near Infrared Spectroscopy to Detect Intracranial Hemorrhage in Children
Acronym
NIRS
Official Title
A Clinical Assessment of the Reliability of Near Infrared Spectroscopy for the Detection of Intracranial Hemorrhage in Young Children
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
IWK Health Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. This study wants to find a way to detect bleeding inside the head without using a CT scan or MRI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Hemorrhage
Keywords
Near Infrared Spectroscopy, Diagnosis, Children
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NIRS
Arm Type
Experimental
Arm Description
Children who undergo NIRS
Intervention Type
Device
Intervention Name(s)
Near Infrared Spectroscopy (NIRS)
Intervention Description
NIRS of the head is undertaken at the time of CT or MRI examination
Primary Outcome Measure Information:
Title
Sensitivity of NIRS
Time Frame
Study conclusion
Secondary Outcome Measure Information:
Title
specificity of NIRS, positive/negative predictive value
Time Frame
Study conclusion
10. Eligibility
Sex
All
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All children under 3 years of age who undergo a CT of the head or MRI of the head.
Exclusion Criteria:
Lack of parental consent
Neurosurgical intervention between CT/MRI and NIRS scanning.
Scalp hematoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Bellemare, MD
Organizational Affiliation
IWK Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K-6R9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Trial to Determine the Efficacy of Near Infrared Spectroscopy to Detect Intracranial Hemorrhage in Children
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