Quantifying Brain Injury on Computed Tomography in Hospitalized Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

425 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-20

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Lay Summary:

To evaluate a novel early diagnostic tool for hospitalized children with traumatic brain injury.

The Problem: Children who present with decreased level of consciousness after injury require urgent medical attention determined by the type and the severity of injury. Unfortunately, history and physical findings are often unreliable in the first hours after hospitalization, the period in which urgent management decisions must be made for their treatment.

The Solution: A promising tool developed for measuring detectable evidence of traumatic brain injury on routine brain scans. The tool combines features invisible to the human eye but detectable by computer software with expert knowledge.This study will evaluate how well the tool can perform in a real health care setting. It is believed that it will greatly improve the efficacy and quality of care provided to children after traumatic brain injury.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Utility of Performing Brain CT Scan in Non Trauma Patients at the Pediatric Emergency Unit

NCT00456391

Convulsions Increased Intracraneal Pressure

COMPLETED

Traumatic Brain Injury - Knowledge Translation

NCT01453621

Traumatic Brain Injury

COMPLETED PHASE3

Decompressive Craniectomy for Severe Traumatic Brain Injury in Children With Refractory Intracranial Hypertension

NCT03766087

Hypertension Intracranial

WITHDRAWN NA

Contrast Enhanced Ultrasound for Evaluation of Pediatric Abdominal Trauma

NCT01763840

Abdominal Trauma

COMPLETED PHASE1

Evaluation of Diagnoses and Clinical Outcomes in Children Undergoing MRI Scans

NCT06278376

Magnetic Resonance Imaging

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To evaluate a novel early neuroimaging diagnostic tool for hospitalized children with traumatic brain injury.

This tool is used to detect evidence of traumatic brain injury on routine brain scans. The tool combines features invisible to the human eye but detectable by computer software with expert knowledge.This study will evaluate how well the tool can perform in a real health care setting. It is believed that it will greatly improve the efficacy and quality of care provided to children after traumatic brain injury.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Trauma, Brain Pediatric

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Hospitalized with TBI
* Age: less than 18 years of age who undergoes routine head CT in the acute period with any severity of injury based on Glasgow Coma Scale score (3 to15).