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

This study has been completed.

Sponsor:

Information provided by:

IWK Health Centre

ClinicalTrials.gov Identifier:

NCT00795119

First received: November 19, 2008

Last updated: April 2, 2009

Last verified: November 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

November 19, 2008

Last Updated Date

April 2, 2009

Start Date ^ICMJE

September 2007

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Sensitivity of NIRS [ Time Frame: Study conclusion ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00795119 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

specificity of NIRS, positive/negative predictive value [ Time Frame: Study conclusion ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Intracranial Hemorrhage

Intervention ^ICMJE

Device: Near Infrared Spectroscopy (NIRS)

NIRS of the head is undertaken at the time of CT or MRI examination

Study Arm (s)

Experimental: NIRS

Children who undergo NIRS

Intervention: Device: Near Infrared Spectroscopy (NIRS)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 36 Months

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00795119

Other Study ID Numbers ^ICMJE

IWK3748

Has Data Monitoring Committee

Responsible Party

Dr Steven Bellemare, IWK Health Centre, Dalhousie University

Study Sponsor ^ICMJE

IWK Health Centre

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Steven Bellemare, MD

IWK Health Centre

Information Provided By

IWK Health Centre

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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