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

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ClinicalTrials.gov Identifier: NCT00795119
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : April 3, 2009
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment
Intracranial Hemorrhage Device: Near Infrared Spectroscopy (NIRS)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Clinical Assessment of the Reliability of Near Infrared Spectroscopy for the Detection of Intracranial Hemorrhage in Young Children
Study Start Date : September 2007
Primary Completion Date : February 2009
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Sensitivity of NIRS [ Time Frame: Study conclusion ]

Secondary Outcome Measures :
  1. specificity of NIRS, positive/negative predictive value [ Time Frame: Study conclusion ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795119


Locations
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K-6R9
Sponsors and Collaborators
IWK Health Centre
Investigators
Principal Investigator: Steven Bellemare, MD IWK Health Centre
More Information

Responsible Party: Dr Steven Bellemare, IWK Health Centre, Dalhousie University
ClinicalTrials.gov Identifier: NCT00795119     History of Changes
Other Study ID Numbers: IWK3748
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: April 3, 2009
Last Verified: November 2008

Keywords provided by IWK Health Centre:
Near Infrared Spectroscopy
Diagnosis
Children

Additional relevant MeSH terms:
Hemorrhage
Intracranial Hemorrhages
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases