Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children
Condition(s) studied
Study 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).
Eligibility
Primary outcome measure(s)
- Number of participants with "clinically important intracranial injury (CIII)" — 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.
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | Malmö | 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 |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05964764 on ClinicalTrials.gov ↗ ← All trials in Sweden