Back to resultsIVF in Pediatric Concussion
Primary Purpose
Pediatric Mild Traumatic Brain Injury
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hypertonic Saline
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Mild Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria:
- History of acute concussion
Exclusion Criteria:
- Other significant medical illness
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interventional 1
Arm Description
Interventional experimental arm with hypertonic saline
Outcomes
Primary Outcome Measures
Postconcussive symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT02214316
First Posted
August 7, 2014
Last Updated
April 27, 2016
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02214316
Brief Title
IVF in Pediatric Concussion
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Study Start Date
October 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
5. Study Description
Brief Summary
Children with concussion may improve with intravenous fluids.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Mild Traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional 1
Arm Type
Experimental
Arm Description
Interventional experimental arm with hypertonic saline
Intervention Type
Other
Intervention Name(s)
Hypertonic Saline
Primary Outcome Measure Information:
Title
Postconcussive symptoms
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of acute concussion
Exclusion Criteria:
Other significant medical illness
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
Country
United States
12. IPD Sharing Statement
Learn more about this trial
IVF in Pediatric Concussion
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