Brain Injuries, TraumaticSHIPPNCT05964764
Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children
An observational study of Brain Injuries, Traumatic, run by Halmstad County Hospital at 16 sites in 2 countries.
Trial summary
Head injuries are common among children and adolescents, with many of them assessed in emergency departments each year. Most children recover fast, with full resolution of symptoms as headache, dizziness or fatigue. A few, however, develop life-threatening complications (such as bleedings in/around the brain). Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Brain Injuries, Traumatic
- How many people
- 5,300 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 1 Apr 2018to 31 Dec 2029
- How long will I take part?
- 4 Months
- 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: Target population is children in Scandinavia with recent minor and moderate head trauma seeking care on emergency departments within participating in study.
Who may be able to join
- Age <18 years.
- Minor and moderate blunt head trauma (GCS 9 - 15) seeking medical assessment in an emergency department at a study hospital in Sweden or Norway.
- Within 24 hours of trauma.
- Informed oral consent from one guardian, and child if older than 14 years old, after receiving oral and written information about study.
Who cannot join
- Patient and/or guardian does not wish to participate in the study.
- Patient included in other study that may affect the management/treatment in the emergency department.
- Penetrating head injury (as those will always receive a CT scan).
- Suspected child abuse / non-accidental trauma (NAT) denoted as suspected child abuse where the social services are informed (as they will always receive a CT scan).
- The patient is not a citizen in the participating country and hence difficult to follow up.
Trial locations and contacts
16 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 2 countries
Sweden15 sites, 11 recruiting
- Recruiting
Alingsås Lasarett
Alingsås
Hanna Farahnoosh, MD
- Active, not recruiting
Mälarsjukhuset i Eskilsstuna
Eskilstuna
- Recruiting
Drottning Silvias Barnsjukhus
Gothenburg
Sarah Thornberg, MD
- Recruiting
Halland Hospital Halmstad
Halmstad
Fredrik Wickbom, MD, 004635131000, fredrik.wickbom@regionhalland.se
- Active, not recruiting
Länssjukhuset Ryhov
Jönköping
- Recruiting
Lasarettet i Ljungby
Ljungby
Malin Johansson, MD
- Recruiting
Skåne University Hospital, Lund
Lund
Jorge Sotoca Fernandez, MD
- Recruiting
Skånes Universitetssjukhus Malmö
Malmö
Jorge Sotoca Fernandez, MD
- Recruiting
Mora Lasarett
Mora
Anders Santoft, MD
- Terminated
Örebro Universitetssjukhus
Örebro
- Recruiting
Astrid Lindgren Childrens Hospital, Solna
Stockholm
Kristofer Kjellröier, MD
- Completed
Norra Älvsborgs Länssjukhus
Trollhättan
- Recruiting
Norrland University Hospital, NUS
Umeå
Beatrice Magnusson, MD, PhD
- Recruiting
Halland Hospital Varberg
Varberg
Rasmus Silfver, MD
- Recruiting
Ystad Lasarett
Ystad
Rachel Keeling, MD
Norway1 site, 1 recruiting
- Recruiting
Haukeland Universitetssjukehus
Haukeland
Aqeel Chaudhry, MD
About this study
Official title: A Pragmatic, Prospective, Multicentre Study for the Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children
Head injuries are common among children and adolescents, with many of them assessed in emergency departments each year. Most children recover fast, with full resolution of symptoms as headache, dizziness or fatigue. A few, however, develop life-threatening complications (such as bleedings in/around the brain). It can be difficult to swiftly and accurately identify these patients in the emergency department. To aid in this task, decision support tools has been developed.
The goal of this observational study is to evaluate a Scandinavian tool developed to aid in management of children with head injuries seeking care in an emergency department.
Read more
The main research question is:
- Are the Scandinavian guidelines for management of mild and moderate head trauma in children sensitive for patient-important outcomes?
Patients will be given the same treatment and recommendations for their head injury no matter if they participate or not in the study, as there is no intervention/ treatment group.
The doctor or nurse managing the child will collect information on patient history, signs and symptoms in the emergency department and management in an electronic case report form. Information on how the recovery period is collected both from medical records >1 month after the emergency department visit, as well as via electronic questionnaires sent to the guardian at 1 month, 3 months and 4 months after the injury via e-mail and/or text message. Long-term outcome will also be examined (>6 months).
Read the detailed description
Design:
This is a pragmatic, prospective, multicentre, observational study of children presenting with mild or moderate traumatic brain injury (TBI) in a general or paediatric emergency department (ED) at hospitals in Scandinavia. A complete data set for analysis including predictor variables and outcome data for the six guidelines included in the study will be registered (SNC2016, PECARN, CATCH, CHALICE, PREDICT, NICE23). There are no interventions as the study is observational. Attending physicians and nurses are instructed to manage children in accordance with the hospital's ordinary guidelines and follow local treatment traditions.
Study setting and population:
The study will be set in Sweden and Norway. Hospitals with different trauma capacities will participate; invitations are sent to units which on daily basis mange children with TBI in their department. Efforts are made to establish a representative distribution in participating centres. The coordinating centre is Halmstad Hospital in southern Sweden.
Data registration and follow-up:
Information on management in the emergency department including patient characteristics, injury type and mechanism, patient history, clinical examination results and current medications will be prospectively documented in a web- based case-report form by the triage nurse and/or physician on call.
One month after trauma, the local study coordinator will assess medical records and journals, screening for outcome measures as well as CT findings, when applicable. A follow-up questionnaire will be sent to guardian(s) 1 month, 3 months and 4 months after the child ́s head injury via e-mail and/or text message (long-term follow up at >6 months). Reminders will be re-sent if no answer is received, primarily by e-mail and then twice by text message.
All data will be registered in via web-based case report forms in Entermedic (Entergate AB). Pseudo-anonymized data will be extracted from database and imported to IBM SPSS® Statistics software version 28 for statistical analysis.
Biomarkers:
A sub-study on patients with intermediate risk for intracranial injury and GCS 14-15, in selected study centres will explore biomarkers as predictors for intracranial injury. Venous blood, capillary blood and saliva sample is sampled from the patient in the ED after written informed consent. Sampling is done within 12 hours from the time of the injury. Analysis of biomarker S100B and others, not yet specified, will be analysed in batch at end of sub-study period.
CT examinations:
CT scans are analysed by a board-certified radiologist on the centre where the exam is performed.
Statistics:
The accuracy of the (SNC) guidelines to predict the primary endpoint will be assessed by 95% confidence intervals (CI) for sensitivity, specificity, likelihood ratio, negative predictive value (NPV) and positive predictive value (PPV). Test performance for other internationally recognized clinical decision rules (PECARN, CATCH, CHALICE, NICE, PREDICT) will also be calculated both in application cohorts (defined by each rule specific inclusion and exclusion criteria) and in comparative cohorts (minor head injury cohort = all patients with GCS 13-15; all patient cohort). When assessing CDRs other than SNC16, both rule specific endpoints and in-study defined endpoints will be tested. Secondary endpoints will be assessed using the same methods. Biomarker analysis results in ROC curves for sensitivity / specificity and from these are specific cut-offs that maximize performance for negative predictive value (i.e., to avoid unnecessary CT examinations and/or admission) derived.
Sample size:
The investigators aim to include 5,300 children, but not more than more than 4 years of active enrolment.
Ethics:
Ethical approval was granted from the Regional Ethical Review Board in Lund (approval number 2017/238) and Ethical Review Board in Norway (approval number 1085). Informed verbal consent will be obtained and registered. Patients' data and social security number will be stored and handled accordingly to European Union General Data Protection Regulation (GDPR 2016/679) and applicable Swedish laws.
A detailed protocol describing study methodology and statistical methods will be published before end of inclusion.
- Conditions
- Brain Injuries, Traumatic
- Medical subject headings
- Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with "clinically important intracranial injury (CIII)"
Defined as a composite variable of death, neurosurgery, admission to hospital ward two (2) days or more due to head injury or intubation one (1) day or more due to pathological traumatic CT findings.
Measured: Within 1 week of injury.
Secondary outcomes (24)
Number of participants with death due to head injury
Defined as death as consequence of the TBI
Measured: Within one week; within 3 months.
Number of participants with neurosurgery due to TBI
Defined as need for any neurosurgical procedure or intervention, including sedation and intubation with controlled ventilation for non-surgical injuries such as diffuse axonal injury.
Measured: Within 1 week of injury.
Number of participants with CT findings
Defined as a possibly trauma-related intracranial finding on CT-scan, such as cranial fractures or acute intracranial haemorrhage.
Measured: Within 1 week of injury.
Number of participants with significant CT findings
Defined as a possibly trauma-related intracranial finding on CT-scan, such as cranial fractures or acute intracranial haemorrhage, but not including undislocated skull fractures
Measured: Within 1 week of injury.
Concentration of specific biomarkers in serum and saliva
Biomarker concentration (S-100B, GFAP, UCH-L1, NSE, tau, NF(H and L), H-FABP, SNTF, MBP, miRNAs, IL-10, BTP, SBDP145, MMP9, HGF, IL-6, OPN, SAA, SICAM, leptin, copeptin, fibrinogen, d-dimer, ICAM, VCAM, IL-12, eotaxin, TNFR2 in a group of patients with TBI and GCS 14-15 in ED.
Measured: Sampling at admission to the emergency department
Number of participants admitted to in-hospital observation > 2 days
Admission to a hospital ward two (2) days or more due to TBI.
Measured: Within 3 months from injury
Number of participants admitted to in-hospital observation
Admission to a hospital ward due to TBI, irrespective of duration of observation
Measured: Within 3 months from injury
Number of participants with extended "clinical observation in ED"
Prolonged clinical observation in ED due to TBI
Measured: Within the first day (24 hours) of injury
Duration of clinical observation
Duration of clinical observation (time in ED or time in ED and in-hospital ward)
Measured: Within 1 week of injury.
Number of participants intubated due to TBI
Endotracheal intubation due to TBI
Measured: Within 3 months from injury
Duration of intubation due to TBI
Duration of intubation categorised as <6h, 6-12 h, 13-24h, 25-48 h, 49h-1 week and >1 week.
Measured: Within 3 months from injury
Number of participants referred for cranial CT (cCT) due to head injury.
Referred for cCT due to head injury
Measured: Within 3 months from injury
Number of participants referred for a follow up (re-)cCT due to clinical deterioration.
Referred for re-cCT due to clinical deterioration.
Measured: Within 3 months from injury
Number of participants referred for a cCT due to clinical deterioration during prolonged observation (in ED or on ward).
Referred for (primary) cCT due to clinical deterioration during prolonged clinical observation.
Measured: Within 3 months from injury
Number of participants with need for sedation or intubation during cCT exam
All ages and stratified 0-4 years, 5-14 years and >14 years. Sedation is defined as positive if participant has received a sedative agent (for example propofol or midazolam) during CT scan.
Measured: Within 3 months from injury
Number of participants with presence of outcome as defined by CATCH-rule ("need for neurological intervention" or "brain injury on CT" )
Need for neurological intervention is defined as either death within 7 days secondary to the head injury or need for any of the following procedures within 7 days: craniotomy, elevation of skull fracture, monitoring of intracranial pressure, or insertion of an endotracheal tube for the management of head injury.
Brain injury on CT defined as any acute intracranial finding revealed on CT that was attributable to acute injury, including closed depressed skull fracture.
Measured: Within one week from trauma
Number of participants with presence of outcome as defined by PECARN-rule ("clinically important TBI").
Clinically important TBI is defined as death from TBI, neurosurgical intervention for TBI (intracranial pressure monitoring, elevation of depressed skull fracture, ventriculostomy, haematoma evacuation, lobectomy, tissue debridement, dura repair, or other), intubation of more than 24 h for TBI or hospital admission of 2 nights or more for TBI in association with TBI on CT.
Measured: Within one week from trauma
Number of participants with presence of outcome as defined by CHALICE-rule ("clinically significant intracranial injury" or "presence of skull fracture" or "admission to hospital").
Clinically significant intracranial injury is "defined as death as a result of head injury, requirement for neurosurgical intervention, or marked abnormality on CT.
Measured: Within one week from trauma
Number of participants with presence of outcome as defined by PREDICT-rule ("clinically important intracranial injury in need for intervention").
Clinically important intracranial injury in need for intervention is defined as neurosurgery and/or intensive care due to TBI.
Measured: Within one week from trauma
Number of participants with presence of outcome as defined by NICE23-rule ("clinically important traumatic brain injury")
Clinically important traumatic brain injury is assumed to be the same as in PECRAN, hence defined as death from TBI, neurosurgical intervention for TBI (intracranial pressure monitoring, elevation of depressed skull fracture, ventriculostomy, haematoma evacuation, lobectomy, tissue debridement, dura repair, or other), intubation of more than 24 h for TBI or hospital admission of 2 nights or more for TBI in association with TBI on CT.
Measured: Within one week from trauma
Number of participants reassessed or readmitted due to TBI
Reassessed and sent home from ED, or admitted from ED after reassessment due to prior TBI.
Measured: Within four weeks from trauma
Number of participants transported to other hospital due to TBI
Transport to other hospital due to TBI, irrespective of cause or way of transportation.
Measured: Within 3 months from injury
Time to full recovery
Time to full recovery from TBI
Measured: <1 week, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, not recovered at 3 months
Clinicial utility SNC16 rule
Experienced utility of the SNC16-rule when applied hypothetically on the participating child with TBI, by the managing doctor. Assessed on a 7-step Likert scale.
Measured: At admission to the emergency department.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Apr 2018
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain Injuries, TraumaticStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,300 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Halmstad County Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fredrik Wickbom, Halmstad County Hospital
- Investigators
- Johan Undén, MD, PhD., Study chair, Region Halland and Lund University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964764
- Sponsor's protocol ID
- 220871
- Acronym
- SHIPP
- Status last verified
- Feb 2024
- First submitted
- 22 Jun 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing of de-identified data for all primary and secondary outcome measures will be considered on individual basis after main and secondary analysis has been completed.
Publications
Wickbom F, Thornberg S, Sotoca Fernandez J, Silfver R, Marklund N, Unden J; Scandinavian Neurotrauma Committee. Comparison of predictive tools for management of paediatric mild TBI: a prospective cohort study. EClinicalMedicine. 2025 Sep 9;88:103484. doi: 10.1016/j.eclinm.2025.103484. eCollection 2025 Oct.
PubMed 40979218Wickbom F, Calcagnile O, Marklund N, Unden J. Validation of the Scandinavian guidelines for minor and moderate head trauma in children: protocol for a pragmatic, prospective, observational, multicentre cohort study. BMJ Open. 2024 Apr 3;14(4):e078622. doi: 10.1136/bmjopen-2023-078622.
PubMed 38569695
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic, Prospective, Multicentre Study for the Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children
- ClinicalTrials.gov ID
- NCT05964764
- Acronym / sponsor ID
- SHIPP / 220871
- Conditions
- Brain Injuries, Traumatic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,300 participants (estimated)
- Lead sponsor
- Halmstad County HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 28 Jul 2023 (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.
Head injuries are common among children and adolescents, with many of them assessed in emergency departments each year. Most children recover fast, with full resolution of symptoms as headache, dizziness or fatigue. A few, however, develop life-threatening complications (such as bleedings in/around the brain). It can be difficult to swiftly and accurately identify these patients in the emergency department. To aid in this task, decision support tools has been developed.
The goal of this observational study is to evaluate a Scandinavian tool developed to aid in management of children with head injuries seeking care in an emergency department.
The main research question is:
- Are the Scandinavian guidelines for management of mild and moderate head trauma in children sensitive for patient-important outcomes?
Patients will be given the same treatment and recommendations for their head injury no matter if they participate or not in the study, as there is no intervention/ treatment group.
The doctor or nurse managing the child will collect information on patient history, signs and symptoms in the emergency department and management in an electronic case report form. Information on how the recovery period is collected both from medical records >1 month after the emergency department visit, as well as via electronic questionnaires sent to the guardian at 1 month, 3 months and 4 months after the injury via e-mail and/or text message. Long-term outcome will also be examined (>6 months).
Detailed description
Design:
This is a pragmatic, prospective, multicentre, observational study of children presenting with mild or moderate traumatic brain injury (TBI) in a general or paediatric emergency department (ED) at hospitals in Scandinavia. A complete data set for analysis including predictor variables and outcome data for the six guidelines included in the study will be registered (SNC2016, PECARN, CATCH, CHALICE, PREDICT, NICE23). There are no interventions as the study is observational. Attending physicians and nurses are instructed to manage children in accordance with the hospital's ordinary guidelines and follow local treatment traditions.
Study setting and population:
The study will be set in Sweden and Norway. Hospitals with different trauma capacities will participate; invitations are sent to units which on daily basis mange children with TBI in their department. Efforts are made to establish a representative distribution in participating centres. The coordinating centre is Halmstad Hospital in southern Sweden.
Data registration and follow-up:
Information on management in the emergency department including patient characteristics, injury type and mechanism, patient history, clinical examination results and current medications will be prospectively documented in a web- based case-report form by the triage nurse and/or physician on call.
One month after trauma, the local study coordinator will assess medical records and journals, screening for outcome measures as well as CT findings, when applicable. A follow-up questionnaire will be sent to guardian(s) 1 month, 3 months and 4 months after the child ́s head injury via e-mail and/or text message (long-term follow up at >6 months). Reminders will be re-sent if no answer is received, primarily by e-mail and then twice by text message.
All data will be registered in via web-based case report forms in Entermedic (Entergate AB). Pseudo-anonymized data will be extracted from database and imported to IBM SPSS® Statistics software version 28 for statistical analysis.
Biomarkers:
A sub-study on patients with intermediate risk for intracranial injury and GCS 14-15, in selected study centres will explore biomarkers as predictors for intracranial injury. Venous blood, capillary blood and saliva sample is sampled from the patient in the ED after written informed consent. Sampling is done within 12 hours from the time of the injury. Analysis of biomarker S100B and others, not yet specified, will be analysed in batch at end of sub-study period.
CT examinations:
CT scans are analysed by a board-certified radiologist on the centre where the exam is performed.
Statistics:
The accuracy of the (SNC) guidelines to predict the primary endpoint will be assessed by 95% confidence intervals (CI) for sensitivity, specificity, likelihood ratio, negative predictive value (NPV) and positive predictive value (PPV). Test performance for other internationally recognized clinical decision rules (PECARN, CATCH, CHALICE, NICE, PREDICT) will also be calculated both in application cohorts (defined by each rule specific inclusion and exclusion criteria) and in comparative cohorts (minor head injury cohort = all patients with GCS 13-15; all patient cohort). When assessing CDRs other than SNC16, both rule specific endpoints and in-study defined endpoints will be tested. Secondary endpoints will be assessed using the same methods. Biomarker analysis results in ROC curves for sensitivity / specificity and from these are specific cut-offs that maximize performance for negative predictive value (i.e., to avoid unnecessary CT examinations and/or admission) derived.
Sample size:
The investigators aim to include 5,300 children, but not more than more than 4 years of active enrolment.
Ethics:
Ethical approval was granted from the Regional Ethical Review Board in Lund (approval number 2017/238) and Ethical Review Board in Norway (approval number 1085). Informed verbal consent will be obtained and registered. Patients' data and social security number will be stored and handled accordingly to European Union General Data Protection Regulation (GDPR 2016/679) and applicable Swedish laws.
A detailed protocol describing study methodology and statistical methods will be published before end of inclusion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Target population is children in Scandinavia with recent minor and moderate head trauma seeking care on emergency departments within participating in study.
Key inclusion criteria (4 listed)
- Age <18 years.
- Minor and moderate blunt head trauma (GCS 9 - 15) seeking medical assessment in an emergency department at a study hospital in Sweden or Norway.
- Within 24 hours of trauma.
- Informed oral consent from one guardian, and child if older than 14 years old, after receiving oral and written information about study.
Key exclusion criteria (5 listed)
- Patient and/or guardian does not wish to participate in the study.
- Patient included in other study that may affect the management/treatment in the emergency department.
- Penetrating head injury (as those will always receive a CT scan).
- Suspected child abuse / non-accidental trauma (NAT) denoted as suspected child abuse where the social services are informed (as they will always receive a CT scan).
- The patient is not a citizen in the participating country and hence difficult to follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with "clinically important intracranial injury (CIII)"
Time frame: Within 1 week of injury.
Defined as a composite variable of death, neurosurgery, admission to hospital ward two (2) days or more due to head injury or intubation one (1) day or more due to pathological traumatic CT findings.
24 secondary outcomes
Number of participants with death due to head injury
Time frame: Within one week; within 3 months.
Number of participants with neurosurgery due to TBI
Time frame: Within 1 week of injury.
Number of participants with CT findings
Time frame: Within 1 week of injury.
Number of participants with significant CT findings
Time frame: Within 1 week of injury.
Concentration of specific biomarkers in serum and saliva
Time frame: Sampling at admission to the emergency department
Number of participants admitted to in-hospital observation > 2 days
Time frame: Within 3 months from injury
Number of participants admitted to in-hospital observation
Time frame: Within 3 months from injury
Number of participants with extended "clinical observation in ED"
Time frame: Within the first day (24 hours) of injury
Duration of clinical observation
Time frame: Within 1 week of injury.
Number of participants intubated due to TBI
Time frame: Within 3 months from injury
Duration of intubation due to TBI
Time frame: Within 3 months from injury
Number of participants referred for cranial CT (cCT) due to head injury.
Time frame: Within 3 months from injury
Number of participants referred for a follow up (re-)cCT due to clinical deterioration.
Time frame: Within 3 months from injury
Number of participants referred for a cCT due to clinical deterioration during prolonged observation (in ED or on ward).
Time frame: Within 3 months from injury
Number of participants with need for sedation or intubation during cCT exam
Time frame: Within 3 months from injury
Number of participants with presence of outcome as defined by CATCH-rule ("need for neurological intervention" or "brain injury on CT" )
Time frame: Within one week from trauma
Number of participants with presence of outcome as defined by PECARN-rule ("clinically important TBI").
Time frame: Within one week from trauma
Number of participants with presence of outcome as defined by CHALICE-rule ("clinically significant intracranial injury" or "presence of skull fracture" or "admission to hospital").
Time frame: Within one week from trauma
Number of participants with presence of outcome as defined by PREDICT-rule ("clinically important intracranial injury in need for intervention").
Time frame: Within one week from trauma
Number of participants with presence of outcome as defined by NICE23-rule ("clinically important traumatic brain injury")
Time frame: Within one week from trauma
Number of participants reassessed or readmitted due to TBI
Time frame: Within four weeks from trauma
Number of participants transported to other hospital due to TBI
Time frame: Within 3 months from injury
Time to full recovery
Time frame: <1 week, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, not recovered at 3 months
Clinicial utility SNC16 rule
Time frame: At admission to the emergency department.
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 28 Feb 2024.
- Derived from this study: PubMed 40979218Wickbom F, Thornberg S, Sotoca Fernandez J, Silfver R, Marklund N, Unden J; Scandinavian Neurotrauma Committee. Comparison of predictive tools for management of paediatric mild TBI: a prospective cohort study. EClinicalMedicine. 2025 Sep 9;88:103484. doi: 10.1016/j.eclinm.2025.103484. eCollection 2025 Oct.
- Derived from this study: PubMed 38569695Wickbom F, Calcagnile O, Marklund N, Unden J. Validation of the Scandinavian guidelines for minor and moderate head trauma in children: protocol for a pragmatic, prospective, observational, multicentre cohort study. BMJ Open. 2024 Apr 3;14(4):e078622. doi: 10.1136/bmjopen-2023-078622.
- Study information pageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Sharing of de-identified data for all primary and secondary outcome measures will be considered on individual basis after main and secondary analysis has been completed.
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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.
Johan Undén, MD, PhD. study chair
Region Halland and Lund University, Sweden
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, Traumatic, run by Halmstad County Hospital at 16 sites in 2 countries.
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 5 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Sweden, Norway. 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 Fredrik Wickbom, MD (004635131000, fredrik.wickbom@regionhalland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with "clinically important intracranial injury (CIII)" (time frame: Within 1 week of injury.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05964764, which also lists 2 linked publications.
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 Feb 2024.