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

April 2, 2009 updated by: IWK Health Centre

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K-6R9
        • IWK Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NIRS
Children who undergo NIRS
Device: Near Infrared Spectroscopy (NIRS)
NIRS of the head is undertaken at the time of CT or MRI examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity of NIRS
Time Frame: Study conclusion
Study conclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
specificity of NIRS, positive/negative predictive value
Time Frame: Study conclusion
Study conclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IWK Health Centre

Investigators

  • Principal Investigator: Steven Bellemare, MD, IWK Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

November 19, 2008

First Submitted That Met QC Criteria

November 19, 2008

First Posted (Estimate)

November 21, 2008

Study Record Updates

Last Update Posted (Estimate)

April 3, 2009

Last Update Submitted That Met QC Criteria

April 2, 2009

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IWK3748

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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