Hypertonic Saline for Mild TBI in Pediatric Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-11-30

Brief Summary

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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.

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Detailed Description

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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

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Head Injury, Minor Pediatric Emergency Department Patient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Hypertonic Saline

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

Group Type EXPERIMENTAL

Hypertonic Saline ( 3% Sodium Chloride Saline)

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Normal Saline (0.9% NaCl)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No