Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-01 @ 12:28 AM
Study NCT ID:
NCT07060105
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-11
First Post:
2025-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypertonic Saline for Mild TBI in Pediatric Patients
Sponsor:
University of Texas at Austin
Organization:
Study Overview
Official Title:
Efficacy of Hypertonic Saline as a Treatment for Mild Traumatic Brain Injury in Pediatric Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare two different treatments (normal saline and hypertonic saline) for concussions to see if one makes more of a difference in symptoms that can occur following concussions.
Detailed Description:
This randomized, double-blinded prospective study aims to determine the utility and efficacy of 3% hypertonic saline (HTS) to combat acute and long-term sequelae of TBI. We plan to enroll 74 participants, ages 8-17, who present to the pediatric Emergency Department with a mild TBI. The intervention group (n=37) will receive 5ml/kg of 3% hypertonic saline, and the control group (n=37) will receive 5ml/kg of 0.9% normal saline. There is a maximum volume of 500ml for both fluids. A standardized concussion inventory score will be used to assess the severity of symptoms pre-infusion, and post-infusion. Participants (or their parent/guardian) will be asked to complete two additional inventory scores one week and one month after the injury, of which they will be reimbursed for successful completion. Primary outcomes will be the efficacy of HTS in treating acute and chronic concussion symptomatology, and secondary outcomes will include unscheduled revisits to the ED.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: