The Role of Cerebral Oximetry in Pediatric Concussion Assessment

Terminated

• Conditions: Concussion, Brain; Concussion, Mild; Traumatic Brain Injury

• Registration Number: NCT02036333
• Lead Sponsor: Johns Hopkins University

Brief Summary

The purpose of this study is to determine whether there is a difference in cerebral oxygenation as measured by near-infrared spectroscopy (NIRS) in children with concussion and healthy controls.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-13
• Study First Submitted QC: 2014-01-13
• Study First Posted: 2014-01-15
• Primary Completion: 2015-06-30
• Study Completion: 2015-06-30
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-31
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in mean baseline regional cerebral oxygen saturation as measured by near-infrared spectroscopy between children with mild traumatic brain injury and controls.	At presentation (Day 0)

Secondary Outcome Measures

Name	Time	Method
Difference in the change in regional cerebral oxygen saturation during handgrip exercise between children with mild traumatic brain injury and controls.	At presentation (Day 0)
Difference in Sport Concussion Assessment Tool 2 (SCAT2) total score between patients with mild traumatic brain injury and controls.	At presentation (Day 0)

Trial Locations

Locations (1)

Johns Hopkins University Pediatric Emergency Medicine; 🇺🇸 Baltimore, Maryland, United States