Ireland
--:--IST
Recruiting Observational

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

NCT05964764 · tracked via the Priya Life Science Sweden tracker
Sponsor
Halmstad County Hospital
Phase
Observational
Started
2018-04-01
Last updated
2024-02-28

Condition(s) studied

Brain Injuries, Traumatic

Study summary

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).

Eligibility

Sex
ALL
Min age
—
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Number of participants with "clinically important intracranial injury (CIII)" — Within 1 week of injury.
    Defined as a composite variable of death, neurosurgery, admission to hospital ward two (2) days or more due to head injury or intubation one (1) day or more due to pathological traumatic CT findings.

Trial sites (16)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05964764 on ClinicalTrials.gov ↗ ← All trials in Sweden