NCT07060105

Hypertonic Saline for Mild TBI in Pediatric Patients

Efficacy of Hypertonic Saline as a Treatment for Mild Traumatic Brain Injury in Pediatric Patients

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: University of Texas at Austin · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head Injury, Minor
• Pediatric
• Emergency Department Patient

Interventions

Type	Name	Description
OTHER	Hypertonic Saline ( 3% Sodium Chloride Saline)	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.
OTHER	Normal Saline (0.9% NaCl)	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.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-11-30
• Completion: 2025-11-30
• First posted: 2025-07-11
• Last updated: 2025-07-11

Locations

1 site across 1 country: United States