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
  Purpose

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 Intervention
Intracranial Hemorrhage
Device: Near Infrared Spectroscopy (NIRS)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by IWK Health Centre:

Primary Outcome Measures:
  • Sensitivity of NIRS [ Time Frame: Study conclusion ] [ Designated as safety issue: No ]

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

Enrollment: 73
Study Start Date: September 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 36 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Steven Bellemare, IWK Health Centre, Dalhousie University
ClinicalTrials.gov Identifier: NCT00795119     History of Changes
Other Study ID Numbers: IWK3748
Study First Received: November 19, 2008
Last Updated: April 2, 2009
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on July 31, 2014