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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00795119

Acronym

NIRS

Enrollment

Registered

2008-11-21

Start date

2007-09-30

Completion date

2009-02-28

Last updated

2009-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Hemorrhage

Keywords

Near Infrared Spectroscopy, Diagnosis, Children

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.

Interventions

DEVICENear Infrared Spectroscopy (NIRS)

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 36 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Sensitivity of NIRS	Study conclusion

Secondary

Measure	Time frame
specificity of NIRS, positive/negative predictive value	Study conclusion

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026