Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children

NCT05964764 | Recruiting

• 1 other identifier: 220871
• Study Type: observational
• Target: 5,300
• Locations: 2 countries
• Sites: 16

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).

Conditions

Brain Injuries, Traumatic

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 1 week of injury.

Secondary Outcomes (24)

• Number of participants with death due to head injury

  Within one week; within 3 months.

• Number of participants with neurosurgery due to TBI

  Within 1 week of injury.

• Number of participants with CT findings

  Within 1 week of injury.

• Number of participants with significant CT findings

  Within 1 week of injury.

• Concentration of specific biomarkers in serum and saliva

  Sampling at admission to the emergency department

Other Outcomes (4)

• Participant rating on GOS-E PEDS Score

  3 months after injury

• Participant rating on Post Concussion Symptom Inventory - Parent (PCSI-P) assessment

  3 months after injury.

• Participant rating on Mental Fatigue Scale

  1 month and 4 months after injury.

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Halmstad County Hospital: lead

Study Sites (16)

Haukeland Universitetssjukehus

Haukeland, Norway

RECRUITING

Alingsås Lasarett

Alingsås, Sweden

RECRUITING

Mälarsjukhuset i Eskilsstuna

Eskilstuna, Sweden

ACTIVE NOT RECRUITING

Drottning Silvias Barnsjukhus

Gothenburg, Sweden

RECRUITING

Halland Hospital Halmstad

Halmstad, Sweden

RECRUITING

Länssjukhuset Ryhov

Jönköping, Sweden

ACTIVE NOT RECRUITING

Lasarettet i Ljungby

Ljungby, Sweden

RECRUITING

Skåne University Hospital, Lund

Lund, Sweden

RECRUITING

Skånes Universitetssjukhus Malmö

Malmo, Sweden

RECRUITING

Mora Lasarett

Mora, Sweden

RECRUITING

Örebro Universitetssjukhus

Örebro, Sweden

TERMINATED

Astrid Lindgren Childrens Hospital, Solna

Stockholm, Sweden

RECRUITING

Norra Älvsborgs Länssjukhus

Trollhättan, Sweden

COMPLETED

Norrland University Hospital, NUS

Umeå, Sweden

RECRUITING

Halland Hospital Varberg

Varberg, Sweden

RECRUITING

Ystad Lasarett

Ystad, Sweden

RECRUITING

Related Publications (2)

• 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.

  PMID: 40979218 DERIVED

• Wickbom 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.

  PMID: 38569695 DERIVED

Related Links

• Study information page

Biospecimen

Retention: SAMPLES WITHOUT DNA

In a subgroup of patients (target n=1000) a blood and saliva sample for postponed analysis of biomarkers in TBI will be obtained after written informed consent.

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Johan Undén, MD, PhD.

  Region Halland and Lund University, Sweden

  STUDY CHAIR

Central Study Contacts

Fredrik Wickbom, MD

CONTACT

004635131000; fredrik.wickbom@regionhalland.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 28, 2023
• Study Start: April 1, 2018
• Primary Completion: August 31, 2024
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available on reasonable request up to 10 years after study completion.
• Access Criteria: Investigators whose proposed use of the data has been approved by the study review committee and sharing of requested data is permitted by Swedish and European law.

Locations

NO (1); SE (15)