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 type | Observational |
|---|---|
| Ages | Any age to 17 Years |
| Sex | All |
| Enrollment | 5300 (estimated) |
| Sponsor | Halmstad County Hospital Academic / other |
| Locations | 16 sites (Haukeland and 15 other locations) |
| Status | Recruiting |
| Started | April 1, 2018 |
| Main results expected | August 31, 2024 |
| Study ends | December 31, 2029 |
| Registry record updated | February 28, 2024 |
| Trial ID | NCT05964764 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
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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
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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
- Study coordinator: Fredrik Wickbom, MD
- Email: fredrik.wickbom@regionhalland.se
- Phone: 004635131000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.