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OpenTrials
Completed

NCT Number: NCT00795119

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

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Key information

Conditions

Intracranial Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Disease Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

Up to 36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IWK Health Centre

Halifax, Nova Scotia, B3K-6R9, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Near Infrared Spectroscopy (NIRS)

Device

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

Primary outcomes

  1. Sensitivity of NIRS

    Time frame: Study conclusion

Secondary outcomes

  1. specificity of NIRS, positive/negative predictive value

    Time frame: Study conclusion

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Registry information

Official study title

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

Acronym: NIRS

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 21, 2008
Registry last updated
Apr 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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