Actively Recruiting

Age: 0 - 17Years
All Genders
NCT05964764

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

Age: 0 - 17Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered 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

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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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