Status:

RECRUITING

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

Lead Sponsor:

Halmstad County Hospital

Conditions:

Brain Injuries, Traumatic

Eligibility:

All Genders

Up to 17 years

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, dizzin...

Detailed Description

Design: This is a pragmatic, prospective, multicentre, observational study of children presenting with mild or moderate traumatic brain injury (TBI) in a general or paediatric emergency department (E...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

April 1 2018

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2029

Estimated Enrollment :

5300 Patients enrolled

Trial Details

Trial ID

NCT05964764

Start Date

April 1 2018

End Date

December 31 2029

Last Update

February 28 2024

Active Locations (16)

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Page 1 of 4 (16 locations)

1

Haukeland Universitetssjukehus

Haukeland, Norway

2

Alingsås Lasarett

Alingsås, Sweden

3

Mälarsjukhuset i Eskilsstuna

Eskilstuna, Sweden

4

Drottning Silvias Barnsjukhus

Gothenburg, Sweden