Hypertonic Saline for Mild TBI in Pediatric Patients

NCT07060105 | Active Not Recruiting

• 1 other identifier: 00004358
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Head Injury, Minor; Pediatric; Emergency Department Patient

Outcome Measures

Primary Outcomes (2)

• Concussion symptoms severity

  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.

  One month

• Severity of concussion symptoms

  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.

  One month

Study Arms (2)

Hypertonic Saline

EXPERIMENTAL

The intervention group (n=37) will receive 5ml/kg of 3% hypertonic saline

Other: Hypertonic Saline ( 3% Sodium Chloride Saline)

Normal Saline

ACTIVE COMPARATOR

Control group (n=37) will receive 5ml/kg of 0.9% normal saline

Other: Normal Saline (0.9% NaCl)

Interventions

Hypertonic Saline ( 3% Sodium Chloride Saline) OTHER

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.

Hypertonic Saline

Normal Saline (0.9% NaCl) OTHER

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.

Normal Saline

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 8-17
• Blunt head injury within the past five days with any associated symptoms as outlined in the concussion inventory.
• English or Spanish speaking.
• Glasgow Coma Scale score of 13-15
• Treating provider plans to use saline administration as part of patient's treatment plan

You may not qualify if:

• Intracranial injury diagnosed by CT / MR Brain, though imaging is not a requirement for this study.
• Possible or witnessed posttraumatic seizure
• Developmental delay / intellectual disability
• Underlying cardiac, pulmonary, and renal pathology in which fluid administration or hypertonic saline may potentially be harmful, based on attending provider judgement.
• Suspected use of alcohol or illicit substances
• Associated injuries requiring the use of narcotics for analgesia

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Dell Children's Medical Center

Austin, Texas, 78723, United States

Location

Related Links

• Study information site

MeSH Terms

Conditions

Craniocerebral Trauma

Interventions

Saline Solution, Hypertonic; Saline Solution

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions

Study Officials

• Matthew Wilkinson, MD, MPH

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Coordinator

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 11, 2025
• Study Start: November 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)