Clinical trial Recruiting at 12 sites Observational Ages Any age to 17

Evaluating Scandinavian Guidelines for Managing Head Injuries in Children

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

Run by Halmstad County Hospital · NCT05964764 · Data updated 2026-11-12

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 typeObservational
AgesAny age to 17 Years
SexAll
Enrollment5300 (estimated)
SponsorHalmstad County Hospital
Academic / other
Locations16 sites (Haukeland and 15 other locations)
StatusRecruiting
StartedApril 1, 2018
Main results expectedAugust 31, 2024
Study endsDecember 31, 2029
Registry record updatedFebruary 28, 2024
Trial IDNCT05964764 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

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

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Haukeland Universitetssjukehus
    Haukeland, Norway
    Recruiting
  • Alingsås Lasarett
    Alingsås, Sweden
    Recruiting
  • Drottning Silvias Barnsjukhus
    Gothenburg, Sweden
    Recruiting
  • Halland Hospital Halmstad
    Halmstad, Sweden
    Recruiting
  • Lasarettet i Ljungby
    Ljungby, Sweden
    Recruiting
  • Skåne University Hospital, Lund
    Lund, Sweden
    Recruiting
Show 10 more locations
  • Skånes Universitetssjukhus Malmö
    Malmö, Sweden
    Recruiting
  • Mora Lasarett
    Mora, Sweden
    Recruiting
  • Astrid Lindgren Childrens Hospital, Solna
    Stockholm, Sweden
    Recruiting
  • Norrland University Hospital, NUS
    Umeå, Sweden
    Recruiting
  • Halland Hospital Varberg
    Varberg, Sweden
    Recruiting
  • Ystad Lasarett
    Ystad, Sweden
    Recruiting
  • Mälarsjukhuset i Eskilsstuna
    Eskilstuna, Sweden
    Active not recruiting
  • Länssjukhuset Ryhov
    Jönköping, Sweden
    Active not recruiting
  • Örebro Universitetssjukhus
    Örebro, Sweden
    Terminated
  • Norra Älvsborgs Länssjukhus
    Trollhättan, Sweden
    Completed

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.