Evaluating Scandinavian Guidelines for Managing Head Injuries in Children

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

This study looks at how well current guidelines for treating mild and moderate head injuries work for children visiting emergency rooms in Sweden and Norway.

Quick facts

• Study type: Observational
• Enrollment: 5300 (estimated)
• Ages: N/A to 17 Years
• Sex: All
• Sponsor: Halmstad County Hospital (Academic / other)
• Locations: 16 sites (Haukeland and 15 other locations)
• Trial ID: NCT05964764 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effectiveness of Scandinavian guidelines for managing mild and moderate head trauma in children presenting to emergency departments in Sweden and Norway. It involves a multicenter approach where data on patient characteristics, injury types, and outcomes will be collected from various hospitals. The study will not involve any interventions, as it focuses on evaluating existing management practices and their sensitivity to important patient outcomes. Data will be documented by healthcare professionals and followed up one month post-trauma to assess outcomes.

Who should consider this trial

Good fit: Ideal candidates are children under 18 years old who have experienced minor to moderate blunt head trauma and seek medical assessment within 24 hours of the injury.

Not a fit: Patients with penetrating head injuries or those suspected of child abuse will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the accuracy of identifying children at risk for complications from head injuries, leading to improved patient care.

How similar studies have performed: Previous studies have shown varying success with similar guidelines, but this specific evaluation of Scandinavian guidelines is novel.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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 this trial is running

Haukeland and 15 other locations

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

Study contacts

• Study coordinator: Fredrik Wickbom, MD

Conditions Brain Injuries, Traumatic