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

IWK Health Centre73 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Intracranial Hemorrhage

Interventions

Near Infrared Spectroscopy (NIRS)DEVICE

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

Eligibility

Sex: ALLMax age: 36 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

IWK Health Centre

Halifax, Nova Scotia, Canada

Outcomes

Primary Outcomes

Sensitivity of NIRS

Time frame: Study conclusion

Secondary Outcomes

specificity of NIRS, positive/negative predictive value

Time frame: Study conclusion

Data from ClinicalTrials.gov

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