Actively Recruiting
Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children
Led by Halmstad County Hospital · Updated on 2024-02-28
5300
Participants Needed
16
Research Sites
613 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age less than 18 years
- Minor or moderate blunt head trauma with Glasgow Coma Scale (GCS) score 9 to 15
- Seeking medical assessment in an emergency department at a participating hospital in Sweden or Norway
- Injury occurred within 24 hours before presentation
- Informed oral consent obtained from one guardian and from the child if older than 14 years
You will not qualify if you...
- Patient or guardian does not wish to participate
- Patient enrolled in another study affecting emergency department management
- Penetrating head injury present
- Suspected child abuse or non-accidental trauma with social services involvement
- Patient is not a citizen of the participating country, making follow-up difficult
AI-Screening
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Trial Site Locations
Total: 16 locations
1
Haukeland Universitetssjukehus
Haukeland, Norway
Actively Recruiting
2
Alingsås Lasarett
Alingsås, Sweden
Actively Recruiting
3
Mälarsjukhuset i Eskilsstuna
Eskilstuna, Sweden
Active, Not Recruiting
4
Drottning Silvias Barnsjukhus
Gothenburg, Sweden
Actively Recruiting
5
Halland Hospital Halmstad
Halmstad, Sweden
Actively Recruiting
6
Länssjukhuset Ryhov
Jönköping, Sweden
Active, Not Recruiting
7
Lasarettet i Ljungby
Ljungby, Sweden
Actively Recruiting
8
Skåne University Hospital, Lund
Lund, Sweden
Actively Recruiting
9
Skånes Universitetssjukhus Malmö
Malmö, Sweden
Actively Recruiting
10
Mora Lasarett
Mora, Sweden
Actively Recruiting
11
Örebro Universitetssjukhus
Örebro, Sweden
Terminated
12
Astrid Lindgren Childrens Hospital, Solna
Stockholm, Sweden
Actively Recruiting
13
Norra Älvsborgs Länssjukhus
Trollhättan, Sweden
Completed
14
Norrland University Hospital, NUS
Umeå, Sweden
Actively Recruiting
15
Halland Hospital Varberg
Varberg, Sweden
Actively Recruiting
16
Ystad Lasarett
Ystad, Sweden
Actively Recruiting
Research Team
F
Fredrik Wickbom, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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