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NCT00795119 Clinical Trial

A Trial to Determine the Efficacy of Near Infrared Spectroscopy to Detect Intracranial Hemorrhage in Children

Intracranial Hemorrhage Clinical Trial

— NIRS  

Official title:
A Clinical Assessment of the Reliability of Near Infrared Spectroscopy for the Detection of Intracranial Hemorrhage in Young Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00795119
Other study ID # IWK3748
Secondary ID
Status Completed
Phase N/A
First received November 19, 2008
Last updated April 2, 2009
Start date September 2007
Est. completion date February 2009

Study information
Verified date November 2008
Source IWK Health Centre
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical 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. This study wants to find a way to detect bleeding inside the head without using a CT scan or MRI.

Recruitment information / eligibility
Status Completed
Enrollment 73
Est. completion date February 2009
Est. primary completion date February 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 36 Months
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Device:
• Near Infrared Spectroscopy (NIRS)
NIRS of the head is undertaken at the time of CT or MRI examination

Locations
Country Name City State
Canada IWK Health Centre Halifax Nova Scotia

Sponsors (1)
Lead Sponsor Collaborator
IWK Health Centre

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity of NIRS Study conclusion No
Secondary specificity of NIRS, positive/negative predictive value Study conclusion No
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