Actively Recruiting
Study to Validate Scandinavian Guidelines for Managing Mild and Moderate Head Injuries in Children Under 18
Led by Halmstad County Hospital · Updated on 2024-02-28
5300
Participants Needed
16
Research Sites
278 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a Scandinavian decision support tool designed to help manage children with mild and moderate head injuries who seek care in emergency departments. The study focuses on whether these guidelines can reliably identify children with important complications, such as bleeding in or around the brain, following head trauma. This is a prospective, multicenter observational study including hospitals in Sweden and Norway that routinely treat children with traumatic brain injuries. The study involves no changes to usual care all children receive standard management regardless of participation. Data is collected on patient history, symptoms, and treatment during the emergency visit and entered into electronic case report forms. Follow-up is conducted through medical records and electronic questionnaires sent to guardians at 1, 3, and 4 months after injury, with long-term outcomes assessed beyond 6 months. A sub-study will also explore blood and saliva biomarkers to predict brain injury in certain cases. Participants will be monitored through clinical examinations, CT scan results, and questionnaires about recovery. The study measures outcomes like clinically important brain injury within one week, need for neurosurgery, CT findings, hospital admission, and time to full recovery. Safety and long-term effects are followed for up to four years. Data is analyzed to assess how well the Scandinavian and other international guidelines predict outcomes for children with head trauma.
CONDITIONS
Brief Title
Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children
Research Team
F
Fredrik Wickbom, MD
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