Clinical trial NCT05964764: Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children
Official title: A Pragmatic, Prospective, Multicentre Study for the Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Injuries, Traumatic
Lead sponsor: Halmstad County Hospital
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 5300
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Target population is children in Scandinavia with recent minor and moderate head trauma seeking care on emergency departments within participating in study.

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of participants with "clinically important intracranial injury (CIII)"
timeFrame: Within 1 week of injury.
Secondary outcomes:
measure: Number of participants with death due to head injury
timeFrame: Within one week; within 3 months.
measure: Number of participants with neurosurgery due to TBI
timeFrame: Within 1 week of injury.
measure: Number of participants with CT findings
timeFrame: Within 1 week of injury.
measure: Number of participants with significant CT findings
timeFrame: Within 1 week of injury.
measure: Concentration of specific biomarkers in serum and saliva
timeFrame: Sampling at admission to the emergency department
measure: Number of participants admitted to in-hospital observation > 2 days
timeFrame: Within 3 months from injury
measure: Number of participants admitted to in-hospital observation
timeFrame: Within 3 months from injury
measure: Number of participants with extended "clinical observation in ED"
timeFrame: Within the first day (24 hours) of injury
measure: Duration of clinical observation
timeFrame: Within 1 week of injury.
measure: Number of participants intubated due to TBI
timeFrame: Within 3 months from injury
measure: Duration of intubation due to TBI
timeFrame: Within 3 months from injury
measure: Number of participants referred for cranial CT (cCT) due to head injury.
timeFrame: Within 3 months from injury
measure: Number of participants referred for a follow up (re-)cCT due to clinical deterioration.
timeFrame: Within 3 months from injury
measure: Number of participants referred for a cCT due to clinical deterioration during prolonged observation (in ED or on ward).
timeFrame: Within 3 months from injury
measure: Number of participants with need for sedation or intubation during cCT exam
timeFrame: Within 3 months from injury
measure: Number of participants with presence of outcome as defined by CATCH-rule ("need for neurological intervention" or "brain injury on CT" )
timeFrame: Within one week from trauma
measure: Number of participants with presence of outcome as defined by PECARN-rule ("clinically important TBI").
timeFrame: Within one week from trauma
measure: 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").
timeFrame: Within one week from trauma
measure: Number of participants with presence of outcome as defined by PREDICT-rule ("clinically important intracranial injury in need for intervention").
timeFrame: Within one week from trauma
measure: Number of participants with presence of outcome as defined by NICE23-rule ("clinically important traumatic brain injury")
timeFrame: Within one week from trauma
measure: Number of participants reassessed or readmitted due to TBI
timeFrame: Within four weeks from trauma
measure: Number of participants transported to other hospital due to TBI
timeFrame: Within 3 months from injury
measure: Time to full recovery
timeFrame: <1 week, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, not recovered at 3 months
measure: Clinicial utility SNC16 rule
timeFrame: At admission to the emergency department.
Other outcomes:
measure: Participant rating on GOS-E PEDS Score
timeFrame: 3 months after injury
measure: Participant rating on Post Concussion Symptom Inventory - Parent (PCSI-P) assessment
timeFrame: 3 months after injury.
measure: Participant rating on Mental Fatigue Scale
timeFrame: 1 month and 4 months after injury.
measure: Long-term outcome
timeFrame: 5 years post TBI
Locations:
city: Haukeland
country: Norway
facility: Haukeland Universitetssjukehus
city: Alingsås
country: Sweden
facility: Alingsås Lasarett
city: Eskilstuna
country: Sweden
facility: Mälarsjukhuset i Eskilsstuna
city: Göteborg
country: Sweden
facility: Drottning Silvias Barnsjukhus
city: Halmstad
country: Sweden
facility: Halland Hospital Halmstad
city: Jönköping
country: Sweden
facility: Länssjukhuset Ryhov
city: Ljungby
country: Sweden
facility: Lasarettet i Ljungby
city: Lund
country: Sweden
facility: Skåne University Hospital, Lund
city: Malmö
country: Sweden
facility: Skånes Universitetssjukhus Malmö
city: Mora
country: Sweden
facility: Mora Lasarett
city: Stockholm
country: Sweden
facility: Astrid Lindgren Childrens Hospital, Solna
city: Trollhättan
country: Sweden
facility: Norra Älvsborgs Länssjukhus
city: Umeå
country: Sweden
facility: Norrland University Hospital, NUS
city: Varberg
country: Sweden
facility: Halland Hospital Varberg
city: Ystad
country: Sweden
facility: Ystad Lasarett
city: Örebro
country: Sweden
facility: Örebro Universitetssjukhus
Study officials:
affiliation: Region Halland and Lund University, Sweden
name: Johan Undén, MD, PhD.
role: STUDY_CHAIR
References: