Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection in Children

Completed

Conditions studied: Intracranial Hematoma

In brief

This is a study to determine whether the Near infrared spectroscopy (NIRS) optical density (OD) measurement with an Infrascanner device accurately identifies the presence of an intracranial hematoma in pediatric patients ≤18 years of age after known or suspected traumatic brain injury compared with head computerized tomography (CT) scans as the gold standard.

Key facts

Study ID

NCT02149082

Run by

Children's Hospital of Philadelphia

People needed

465

Starts

2014-06-01

Expected to finish

2018-09-01

Last updated by the study team

2018-11-07

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females ≤18 years admitted to the Children's Hospital of Philadelphia (CHOP) ED or PICU with a known or suspected traumatic head injury undergoing a head CT scan to evaluate for the presence of an intracranial hematoma.
• Head injury occurred <12 hours prior to presentation for the initial CT scan, or the subject had a clinical change prompting repeat CT scanning.

You may not qualify if…

• Evidence of extensive scalp injury including lacerations, avulsions, or abrasions that will impair proper coupling of the Infrascanner device to the subject's head or prevent placement of the device in the specified locations.
• History of neurosurgical procedure (e.g. decompressive craniectomy) with residual bone flap.

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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