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

NCT ID: NCT00795119

Last Updated: 2009-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Intracranial Hemorrhage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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NIRS

Children who undergo NIRS

Group Type EXPERIMENTAL

Near Infrared Spectroscopy (NIRS)

Intervention Type DEVICE

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

Interventions

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Near Infrared Spectroscopy (NIRS)

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

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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IWK Health Centre

OTHER

Sponsor Role lead

Responsible Party

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IWK Health Centre, Dalhousie University

Principal Investigators

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Steven Bellemare, MD

Role: PRINCIPAL_INVESTIGATOR

IWK Health Centre

Locations

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IWK Health Centre

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

Other Identifiers

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IWK3748

Identifier Type: -

Identifier Source: org_study_id

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