Pediatric Mild Traumatic Brain InjuryPhase 1/2NCT02214316
IVF in Pediatric Concussion
A Phase 1/2 study testing Hypertonic Saline in people with Pediatric Mild Traumatic Brain Injury, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Children with concussion may improve with intravenous fluids. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Pediatric Mild Traumatic Brain Injury
- What is being tested?
- Hypertonic Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Apr 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- History of acute concussion
Who cannot join
- Other significant medical illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri
About this study
Children with concussion may improve with intravenous fluids.
- Conditions
- Pediatric Mild Traumatic Brain Injury
- Being tested
- Hypertonic Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic SalineOther
| Study group | Role | What they receive |
|---|---|---|
| Interventional 1 | Experimental | Interventional experimental arm with hypertonic saline Receives: Other: Hypertonic Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postconcussive symptoms
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startOct 2015
- Primary completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214316
- Sponsor's protocol ID
- 201408006
- Status last verified
- Apr 2016
- First submitted
- 7 Aug 2014
- Last updated
- 28 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IVF in Pediatric Concussion
- ClinicalTrials.gov ID
- NCT02214316
- Acronym / sponsor ID
- 201408006
- Conditions
- Pediatric Mild Traumatic Brain Injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (actual)
- First posted
- 12 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children with concussion may improve with intravenous fluids.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional 1 | Experimental | Other: Hypertonic SalineInterventional experimental arm with hypertonic saline |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- History of acute concussion
Key exclusion criteria (1 listed)
- Other significant medical illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypertonic Saline | Other | Interventional 1 |
Primary outcome
Postconcussive symptoms
Time frame: 3 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
Related trials for Pediatric Mild Traumatic Brain Injury
Not yet recruiting
Kids Injury Detection Study Using the i-STAT
Mild Traumatic Brain Injury, Pediatric Traumatic Brain Injury
Recruiting
Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function After Pediatric Concussion (Acute Phase)
Concussion, Mild Traumatic Brain Injury
Not yet recruiting
Mindfulness-Based Intervention for Pediatric Mild Traumatic Brain Injury
Concussions, Mild Traumatic Brain Injury, Concussion
Active, not recruiting
Hypertonic Saline for Mild TBI in Pediatric Patients
Head Injury, Minor, Pediatric
Active, not recruiting
Mobile Subthreshold Exercise Program for Concussion--R01
Concussion, Brain, Concussion, Mild
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hypertonic Saline in people with Pediatric Mild Traumatic Brain Injury, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postconcussive symptoms (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2016.