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A Pragmatic, Prospective, Multicentre Study for the Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children

Status: Recruiting
Location: See all (16) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Norway
Haukeland Universitetssjukehus
RECRUITING
Haukeland
Sweden
Alingsås Lasarett
RECRUITING
Alingsås
Mälarsjukhuset i Eskilsstuna
ACTIVE_NOT_RECRUITING
Eskilstuna
Drottning Silvias Barnsjukhus
RECRUITING
Gothenburg
Halland Hospital Halmstad
RECRUITING
Halmstad
Länssjukhuset Ryhov
ACTIVE_NOT_RECRUITING
Jönköping
Lasarettet i Ljungby
RECRUITING
Ljungby
Skåne University Hospital, Lund
RECRUITING
Lund
Skånes Universitetssjukhus Malmö
RECRUITING
Malmo
Mora Lasarett
RECRUITING
Mora
Örebro Universitetssjukhus
TERMINATED
Örebro
Astrid Lindgren Childrens Hospital, Solna
RECRUITING
Stockholm
Norra Älvsborgs Länssjukhus
COMPLETED
Trollhättan
Norrland University Hospital, NUS
RECRUITING
Umeå
Halland Hospital Varberg
RECRUITING
Varberg
Ystad Lasarett
RECRUITING
Ystad
Contact Information
Primary
Fredrik Wickbom, MD
fredrik.wickbom@regionhalland.se
004635131000
Time Frame
Start Date: 2018-04-01
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 5300
Related Therapeutic Areas
Sponsors
Leads: Halmstad County Hospital

This content was sourced from clinicaltrials.gov