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

Recruiting now

Conditions studied: Brain Injuries, Traumatic

In brief

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).

Key facts

Study ID

NCT05964764

Run by

Halmstad County Hospital

People needed

5300

Starts

2018-04-01

Expected to finish

2029-12-31

Last updated by the study team

2024-02-28

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ystad Lasarett — Ystad, Sweden (enrolling)
• Alingsås Lasarett — Alingsås, Sweden (enrolling)
• Astrid Lindgren Childrens Hospital, Solna — Stockholm, Sweden (enrolling)
• Norrland University Hospital, NUS — Umeå, Sweden (enrolling)
• Halland Hospital Varberg — Varberg, Sweden (enrolling)
• Haukeland Universitetssjukehus — Haukeland, Norway (enrolling)
• Drottning Silvias Barnsjukhus — Gothenburg, Sweden (enrolling)
• Halland Hospital Halmstad — Halmstad, Sweden (enrolling)
• Lasarettet i Ljungby — Ljungby, Sweden (enrolling)
• Skåne University Hospital, Lund — Lund, Sweden (enrolling)
• Skånes Universitetssjukhus Malmö — Malmö, Sweden (enrolling)
• Mora Lasarett — Mora, Sweden (enrolling)
• Mälarsjukhuset i Eskilsstuna — Eskilstuna, Sweden
• Örebro Universitetssjukhus — Örebro, Sweden
• Norra Älvsborgs Länssjukhus — Trollhättan, Sweden
• Länssjukhuset Ryhov — Jönköping, Sweden

Full record on ClinicalTrials.gov

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