Pediatric Traumatic Brain InjuryNCT06940232
Validating a Blood Test for the Detection of Traumatic Brain Injury in Children
An observational study of Pediatric Traumatic Brain Injury, run by University of Nebraska at 1 site in United States.
Trial summary
The primary objective of this study is to establish if Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) are predictive of computed tomography (CT) findings in pediatric traumatic brain injuries (TBI). Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Pediatric Traumatic Brain Injury
- What is being tested?
- Blood Test for Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) Acute Biomarkers
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients under the age of 18 (0-17) who present to the emergency room in the setting of non-penetrating trauma and blood draw within 24 hours of injury will be screened. All participants who present as a trauma activation will automatically have blood drawn as part of the trauma protocol. Participants with head trauma who do not present as a trauma activation (i.e. arrived via private auto) will have labs drawn at the discretion of the treating physician.
Who may be able to join
- 0-17 years of age
- Presentation of non-penetrating trauma
- Blood draw within 24 hours of injury
- For TBI group: head CT or MRI obtained
Who cannot join
- Presentation to Children's Nebraska after 24 hours of injury
- 18 years of age or older
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Nebraska
Omaha, Nebraska, 68114
Megan McChesney, BSN, RN, CPN, 531-375-3835, mmcchesney@unmc.edu
Grace Lai, MD, PhD
About this study
Official title: Ubiquitin C-terminal Hydrolase L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) as Acute Biomarkers for Prediction of Traumatic Brain Injury (TBI) in Children
The primary objective of this study is to establish if Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) are predictive of computed tomography (CT) findings in pediatric traumatic brain injuries (TBI). The participant population is pediatric patients, ages 0 to less than 18 years old with a possible TBI or trauma-related injury who have blood drawn per standard of care in the emergency department. Blood samples will be analyzed using the i-STAT TBI cartridge (Abbott Laboratories, Abbott Park, IL, USA) by the Emergency Department charge nurse within one hour of collection of the blood sample. Clinical outcomes will be assessed via telephone interview with a parent at 3 and 6 months for all surviving TBI patients.
Read the detailed description
The Centers for Disease Control and Prevention (CDC) estimates 3,000 deaths annually in children and youth from traumatic brain injury (TBI), 29,000 hospitalizations, and 400,000 emergency room visits . A prospective study lead by the Pediatric Emergency Care Applied Research Network (PECARN) reported that 35.5% of 40,000 children who presented with a mild TBI (Glasgow Coma Scale, GCS, 14-15) had a head computed tomography (CT) scan, of which only 0.9% were clinically significant, and 0.1% required neurosurgical intervention, which led to the development of an algorithm for the need for CT imaging in pediatric mild TBI. However, a large scale study of the National Hospital Ambulatory Care Medical Survey database from 2008-2015 did not show a decrease in children undergoing CT imaging. Thus, there is still a need for a more definitive means to predict intracranial injury to avoid radiation exposure in children.
In 2018, the US Food and Drug Administration (FDA) approved the first blood test to assess mild TBI for adults with suspected brain injury. A portable point-of-care platform was made available that could detect concentrations of serum and plasma concentrations of Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) in 15 minutes to predict evidence of intra-cranial hemorrhage on CT. Although not yet FDA approved in children, some studies showed that GFAP and UCH-L1 were able to distinguish children with concussive symptoms from body trauma controls, while others showed significantly higher levels of GFAP, but not UCH-L1. These studies did not test the hypothesis of serum biomarkers for prediction of evidence of intracranial injury on cranial imaging. Thus, further studies are needed to determine if these biomarkers can be used in the pediatric population to predict degree of intracranial injury.
Investigators propose a prospective case-control study that is comprised of three groups: participants with mild TBI, Glasgow Coma Scale (GCS) 13-15, participants with moderate to severe TBI (GCS <13), and a control group that includes other trauma participants with no history of head injury. Patients under the age of 18 (0-17) who present to the emergency room in the setting of non-penetrating trauma will be screened. All patients with blood obtained for clinical purposes will be included in the study. Written consent for prospective follow-up will be obtained from parents prior to discharge from the hospital. Participant demographic and clinical information will be abstracted from chart review.
The aims of the study are to determine GFAP and UCH-L1 levels within 24 hours of head injury in children with moderate/severe TBI (GCS 3-12) compared to those with mild TBI (GCS 13-15) and trauma patients without clinical concern for TBI, to determine if serum GFAP and UCH-L1 levels are higher in children with TBI and an abnormal head CT scan compared to those with TBI and normal head CT scan, and to determine if higher serum GFAP and UCH-L1 are predictive of worse clinical outcomes 3 and 6 months after TBI via the Post-Concussion Symptom Inventory and the Pediatric Cerebral Performance Category Scale surveys.
- Conditions
- Pediatric Traumatic Brain Injury
- Being tested
- Blood Test for Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) Acute Biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Test for Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) Acute BiomarkersDiagnostic test
All groups will have blood drawn per standard of care. Blood samples will be analyzed using Traumatic Brain Injury (TBI) cartridges for iSTAT Alinity device.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Traumatic Brain Injury With Positive Head Computed Tomography Findings | Group 1 will be 110 participants who had a traumatic brain injury (TBI) with positive head computed tomography (HCT). Receives: Diagnostic Test: Blood Test for Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) Acute Biomarkers | |
| Group 2 - Traumatic Brain Injury With Negative Head Computed Tomography Findings | Group 2 will be 110 participants with a known traumatic brain injury (TBI), but a negative head computed tomography (HCT). Receives: Diagnostic Test: Blood Test for Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) Acute Biomarkers | |
| Group 3 - All Other Trauma Participants With No History of Head Injury | Group 3 will be 110 participants being treated for a traumatic injury with no history of head injury. Receives: Diagnostic Test: Blood Test for Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) Acute Biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Serum Glial Fibrillary Acidic Protein Levels, an Acute Biomarker, Among Children With Traumatic Brain Injury and Control Groups
Serum Glial Fibrillary Acidic Protein (GFAP) levels measured with a i-STAT TBI cartridge within 24 hours of head injury will be compared in children with moderate/severe traumatic brain injury (TBI), Glasgow Coma Scale (GCS) 3-12, mild TBI (GCS 13-15) and trauma participants without clinical concern for TBI.
Measured: Within 24 hours of injury
Comparison of Ubiquitin C-terminal Hydrolase L1 Levels, an Acute Biomarker, Among Children With Traumatic Brain Injury and Control Groups
Serum Ubiquitin C-terminal Hydrolase L1 (UCH-L1) levels measured with a i-STAT TBI cartridge within 24 hours of head injury will be compared in children with moderate/severe traumatic brain injury (TBI), Glasgow Coma Scale (GCS) 3-12, mild TBI (GCS 13-15) and trauma participants without clinical concern for TBI.
Measured: Within 24 hours of injury
Comparison of Serum Glial Fibrillary Acidic Protein Levels, an Acute Biomarker, Between Children With Traumatic Brain Injury With Normal and Abnormal Head Computed Tomography Scan
Serum Glial Fibrillary Acidic Protein (GFAP) measured with a i-STAT TBI cartridge within 24 hours of traumatic brain injury (TBI) and a normal head computed tomography (CT) scan will be compared to levels in children with TBI and an abnormal head computed tomography (CT) scan.
Measured: Within 24 hours of injury
Comparison of Ubiquitin C-terminal Hydrolase L1 Levels, an Acute Biomarker, in Children With Traumatic Brain Injury With Normal and Abnormal Head Computed Tomography Scan
Serum Ubiquitin C-terminal Hydrolase L1 (UCH-L1) levels in children with traumatic brain injury (TBI) and a normal head computed tomography (CT) scan will be compared to levels in children with (TBI) and an abnormal head computed tomography (CT) scan.
Measured: Within 24 hours of injury
Comparison of Serum Glial Fibrillary Acidic Protein Levels, an Acute Biomarker, and Clinical Outcomes in Children With Traumatic Brain Injury Using Post-Concussion Symptom Inventory
Serum Glial Fibrillary Acidic Protein (GFAP) levels in children with traumatic brain injury (TBI) will be compared to clinical outcomes using the Post-Concussion Symptom Inventory. The Inventory rates 23 symptoms from 0 (none) to 6 (severe).
Measured: 3 months and 6 months after traumatic brain injury
Comparison of Ubiquitin C-terminal Hydrolase L1 Levels, an Acute Biomarker, and Clinical Outcomes in Children With Traumatic Brain Injury Using Post-Concussion Symptom Inventory
Serum Ubiquitin C-terminal Hydrolase L1 (UCH-L1) levels in children with traumatic brain injury (TBI) will be compared to clinical outcomes using the Post-Concussion Symptom Inventory. The Inventory rates 23 symptoms from 0 (none) to 6 (severe).
Measured: 3 months and 6 months after traumatic brain injury
Comparison of Serum Glial Fibrillary Acidic Protein Levels, an Acute Biomarker, and Clinical Outcomes in Children With Traumatic Brain Injury Using Pediatric Cerebral Performance Category Scale
Serum Glial Fibrillary Acidic Protein (GFAP) levels in children with traumatic brain injury (TBI) will be compared to clinical outcomes using the Pediatric Cerebral Performance Category Scale. This scale rates 5 functional categories from 1 (normal) to 6 (vegetative state).
Measured: 3 months and 6 months after traumatic brain injury
Comparison of Ubiquitin C-terminal Hydrolase L1 Levels, an Acute Biomarker, and Clinical Outcomes in Children With Traumatic Brain Injury Using Pediatric Cerebral Performance Category Scale
Serum Ubiquitin C-terminal Hydrolase L1 (UCH-L1) levels in children with traumatic brain injury (TBI) will be compared to clinical outcomes using the Pediatric Cerebral Performance Category Scale. This scale rates 5 functional categories from 1 (normal) to 6 (vegetative state).
Measured: 3 months and 6 months after traumatic brain injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start14 May 2025
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Traumatic Brain InjuryStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grace Lai, MD, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940232
- Sponsor's protocol ID
- 0423-24-EP
- Status last verified
- Jun 2026
- First submitted
- 14 Apr 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ubiquitin C-terminal Hydrolase L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) as Acute Biomarkers for Prediction of Traumatic Brain Injury (TBI) in Children
- ClinicalTrials.gov ID
- NCT06940232
- Acronym / sponsor ID
- 0423-24-EP
- Conditions
- Pediatric Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 14 May 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Apr 2025 (actual)
- 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.
The primary objective of this study is to establish if Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) are predictive of computed tomography (CT) findings in pediatric traumatic brain injuries (TBI). The participant population is pediatric patients, ages 0 to less than 18 years old with a possible TBI or trauma-related injury who have blood drawn per standard of care in the emergency department. Blood samples will be analyzed using the i-STAT TBI cartridge (Abbott Laboratories, Abbott Park, IL, USA) by the Emergency Department charge nurse within one hour of collection of the blood sample. Clinical outcomes will be assessed via telephone interview with a parent at 3 and 6 months for all surviving TBI patients.
Detailed description
The Centers for Disease Control and Prevention (CDC) estimates 3,000 deaths annually in children and youth from traumatic brain injury (TBI), 29,000 hospitalizations, and 400,000 emergency room visits . A prospective study lead by the Pediatric Emergency Care Applied Research Network (PECARN) reported that 35.5% of 40,000 children who presented with a mild TBI (Glasgow Coma Scale, GCS, 14-15) had a head computed tomography (CT) scan, of which only 0.9% were clinically significant, and 0.1% required neurosurgical intervention, which led to the development of an algorithm for the need for CT imaging in pediatric mild TBI. However, a large scale study of the National Hospital Ambulatory Care Medical Survey database from 2008-2015 did not show a decrease in children undergoing CT imaging. Thus, there is still a need for a more definitive means to predict intracranial injury to avoid radiation exposure in children.
In 2018, the US Food and Drug Administration (FDA) approved the first blood test to assess mild TBI for adults with suspected brain injury. A portable point-of-care platform was made available that could detect concentrations of serum and plasma concentrations of Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) in 15 minutes to predict evidence of intra-cranial hemorrhage on CT. Although not yet FDA approved in children, some studies showed that GFAP and UCH-L1 were able to distinguish children with concussive symptoms from body trauma controls, while others showed significantly higher levels of GFAP, but not UCH-L1. These studies did not test the hypothesis of serum biomarkers for prediction of evidence of intracranial injury on cranial imaging. Thus, further studies are needed to determine if these biomarkers can be used in the pediatric population to predict degree of intracranial injury.
Investigators propose a prospective case-control study that is comprised of three groups: participants with mild TBI, Glasgow Coma Scale (GCS) 13-15, participants with moderate to severe TBI (GCS <13), and a control group that includes other trauma participants with no history of head injury. Patients under the age of 18 (0-17) who present to the emergency room in the setting of non-penetrating trauma will be screened. All patients with blood obtained for clinical purposes will be included in the study. Written consent for prospective follow-up will be obtained from parents prior to discharge from the hospital. Participant demographic and clinical information will be abstracted from chart review.
The aims of the study are to determine GFAP and UCH-L1 levels within 24 hours of head injury in children with moderate/severe TBI (GCS 3-12) compared to those with mild TBI (GCS 13-15) and trauma patients without clinical concern for TBI, to determine if serum GFAP and UCH-L1 levels are higher in children with TBI and an abnormal head CT scan compared to those with TBI and normal head CT scan, and to determine if higher serum GFAP and UCH-L1 are predictive of worse clinical outcomes 3 and 6 months after TBI via the Post-Concussion Symptom Inventory and the Pediatric Cerebral Performance Category Scale surveys.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Traumatic Brain Injury With Positive Head Computed Tomography Findings | – | Diagnostic Test: Blood Test for Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) Acute BiomarkersGroup 1 will be 110 participants who had a traumatic brain injury (TBI) with positive head computed tomography (HCT). |
| Group 2 - Traumatic Brain Injury With Negative Head Computed Tomography Findings | – | Diagnostic Test: Blood Test for Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) Acute BiomarkersGroup 2 will be 110 participants with a known traumatic brain injury (TBI), but a negative head computed tomography (HCT). |
| Group 3 - All Other Trauma Participants With No History of Head Injury | – | Diagnostic Test: Blood Test for Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) Acute BiomarkersGroup 3 will be 110 participants being treated for a traumatic injury with no history of head injury. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients under the age of 18 (0-17) who present to the emergency room in the setting of non-penetrating trauma and blood draw within 24 hours of injury will be screened. All participants who present as a trauma activation will automatically have blood drawn as part of the trauma protocol. Participants with head trauma who do not present as a trauma activation (i.e. arrived via private auto) will have labs drawn at the discretion of the treating physician.
Key inclusion criteria (4 listed)
- 0-17 years of age
- Presentation of non-penetrating trauma
- Blood draw within 24 hours of injury
- For TBI group: head CT or MRI obtained
Key exclusion criteria (2 listed)
- Presentation to Children's Nebraska after 24 hours of injury
- 18 years of age or older
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 |
|---|---|---|
| Blood Test for Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1) Acute BiomarkersAll groups will have blood drawn per standard of care. Blood samples will be analyzed using Traumatic Brain Injury (TBI) cartridges for iSTAT Alinity device. | Diagnostic test | Group 1 - Traumatic Brain Injury With Positive Head Computed Tomography Findings, Group 2 - Traumatic Brain Injury With Negative Head Computed Tomography Findings, Group 3 - All Other Trauma Participants With No History of Head Injury |
Primary outcome
Comparison of Serum Glial Fibrillary Acidic Protein Levels, an Acute Biomarker, Among Children With Traumatic Brain Injury and Control Groups
Time frame: Within 24 hours of injury
Serum Glial Fibrillary Acidic Protein (GFAP) levels measured with a i-STAT TBI cartridge within 24 hours of head injury will be compared in children with moderate/severe traumatic brain injury (TBI), Glasgow Coma Scale (GCS) 3-12, mild TBI (GCS 13-15) and trauma participants without clinical concern for TBI.
Comparison of Ubiquitin C-terminal Hydrolase L1 Levels, an Acute Biomarker, Among Children With Traumatic Brain Injury and Control Groups
Time frame: Within 24 hours of injury
Serum Ubiquitin C-terminal Hydrolase L1 (UCH-L1) levels measured with a i-STAT TBI cartridge within 24 hours of head injury will be compared in children with moderate/severe traumatic brain injury (TBI), Glasgow Coma Scale (GCS) 3-12, mild TBI (GCS 13-15) and trauma participants without clinical concern for TBI.
Comparison of Serum Glial Fibrillary Acidic Protein Levels, an Acute Biomarker, Between Children With Traumatic Brain Injury With Normal and Abnormal Head Computed Tomography Scan
Time frame: Within 24 hours of injury
Serum Glial Fibrillary Acidic Protein (GFAP) measured with a i-STAT TBI cartridge within 24 hours of traumatic brain injury (TBI) and a normal head computed tomography (CT) scan will be compared to levels in children with TBI and an abnormal head computed tomography (CT) scan.
Comparison of Ubiquitin C-terminal Hydrolase L1 Levels, an Acute Biomarker, in Children With Traumatic Brain Injury With Normal and Abnormal Head Computed Tomography Scan
Time frame: Within 24 hours of injury
Serum Ubiquitin C-terminal Hydrolase L1 (UCH-L1) levels in children with traumatic brain injury (TBI) and a normal head computed tomography (CT) scan will be compared to levels in children with (TBI) and an abnormal head computed tomography (CT) scan.
Comparison of Serum Glial Fibrillary Acidic Protein Levels, an Acute Biomarker, and Clinical Outcomes in Children With Traumatic Brain Injury Using Post-Concussion Symptom Inventory
Time frame: 3 months and 6 months after traumatic brain injury
Serum Glial Fibrillary Acidic Protein (GFAP) levels in children with traumatic brain injury (TBI) will be compared to clinical outcomes using the Post-Concussion Symptom Inventory. The Inventory rates 23 symptoms from 0 (none) to 6 (severe).
Comparison of Ubiquitin C-terminal Hydrolase L1 Levels, an Acute Biomarker, and Clinical Outcomes in Children With Traumatic Brain Injury Using Post-Concussion Symptom Inventory
Time frame: 3 months and 6 months after traumatic brain injury
Serum Ubiquitin C-terminal Hydrolase L1 (UCH-L1) levels in children with traumatic brain injury (TBI) will be compared to clinical outcomes using the Post-Concussion Symptom Inventory. The Inventory rates 23 symptoms from 0 (none) to 6 (severe).
Comparison of Serum Glial Fibrillary Acidic Protein Levels, an Acute Biomarker, and Clinical Outcomes in Children With Traumatic Brain Injury Using Pediatric Cerebral Performance Category Scale
Time frame: 3 months and 6 months after traumatic brain injury
Serum Glial Fibrillary Acidic Protein (GFAP) levels in children with traumatic brain injury (TBI) will be compared to clinical outcomes using the Pediatric Cerebral Performance Category Scale. This scale rates 5 functional categories from 1 (normal) to 6 (vegetative state).
Comparison of Ubiquitin C-terminal Hydrolase L1 Levels, an Acute Biomarker, and Clinical Outcomes in Children With Traumatic Brain Injury Using Pediatric Cerebral Performance Category Scale
Time frame: 3 months and 6 months after traumatic brain injury
Serum Ubiquitin C-terminal Hydrolase L1 (UCH-L1) levels in children with traumatic brain injury (TBI) will be compared to clinical outcomes using the Pediatric Cerebral Performance Category Scale. This scale rates 5 functional categories from 1 (normal) to 6 (vegetative state).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Pediatric Traumatic Brain Injury
Enrolling by invitationObservational study
Age Related Thresholds for Management of Severe Head Injury in Paediatrics: An Extension of STARSHIP
Traumatic Brain Injury, Pediatric
Not yet recruiting
Kids Injury Detection Study Using the i-STAT
Mild Traumatic Brain Injury, Pediatric Traumatic Brain Injury
RecruitingObservational study
Brain Blood Flow and Cerebral Autoregulation Monitoring in Critically Ill Children
Critical Illness, Pediatric Critical Illness
Not yet recruitingObservational study
Bedside Cranial Ultrasound for Risk-Stratified Imaging in Pediatric Acute Brain Injury
Acute Brain Injury, Traumatic Brain Injury
Not yet recruiting
Creatine Supplementation in Pediatric Brain Injury
Brain Injury, Traumatic Brain Injury
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.
Grace Lai, MD, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Traumatic Brain Injury, run by University of Nebraska 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 14 Aug 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan McChesney, BSN, RN, CPN (531-375-3835, mmcchesney@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Serum Glial Fibrillary Acidic Protein Levels, an Acute Biomarker, Among Children With Traumatic Brain Injury and Control Groups (time frame: Within 24 hours of injury). The study lists 8 primary outcomes in all. 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 14 Aug 2026.