Head Injury, MinorNCT07060105
Hypertonic Saline for Mild TBI in Pediatric Patients
A study testing Hypertonic Saline ( 3% Sodium Chloride Saline) and Normal Saline (0.9% NaCl) in people with Head Injury, Minor and Pediatric, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Head Injury, Minor, Pediatric, Emergency Department Patient
- What is being tested?
- Hypertonic Saline ( 3% Sodium Chloride Saline) and Normal Saline (0.9% NaCl)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 30 Nov 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Hypertonic Saline as a Treatment for Mild Traumatic Brain Injury in Pediatric Patients
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.
Read the 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
- Being tested
- Hypertonic Saline ( 3% Sodium Chloride Saline), Normal Saline (0.9% NaCl)
- Medical subject headings
- Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Hypertonic Saline | Experimental | The intervention group (n=37) will receive 5ml/kg of 3% hypertonic saline Receives: Other: Hypertonic Saline ( 3% Sodium Chloride Saline) |
| Normal Saline | Active comparator | Control group (n=37) will receive 5ml/kg of 0.9% normal saline Receives: Other: Normal Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Nov 2023
- Primary completion30 Nov 2024
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head Injury, MinorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lina Palomares, University of Texas at Austin
- Investigators
- Matthew Wilkinson, MD, MPH, Principal investigator, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060105
- Sponsor's protocol ID
- 00004358
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to maintain participant confidentiality. Aggregate data requests will be reviewed.