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IVF in Pediatric Concussion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02214316
Recruitment Status : Terminated
First Posted : August 12, 2014
Last Update Posted : April 28, 2016
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
Children with concussion may improve with intravenous fluids.

Condition or disease Intervention/treatment Phase
Pediatric Mild Traumatic Brain Injury Other: Hypertonic Saline Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2015
Actual Primary Completion Date : April 2016

Arm Intervention/treatment
Experimental: Interventional 1
Interventional experimental arm with hypertonic saline
Other: Hypertonic Saline



Primary Outcome Measures :
  1. Postconcussive symptoms [ Time Frame: 3 months ]


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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of acute concussion

Exclusion Criteria:

  • Other significant medical illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214316


Locations
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United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States
Sponsors and Collaborators
Washington University School of Medicine

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02214316    
Other Study ID Numbers: 201408006
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating