RecruitingNot Applicable

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

Norway, Sweden5,300 participantsStarted 2018-04-01

Plain-language 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).

Who can participate

Age range

17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with "clinically important intracranial injury (CIII)"

Timeframe: Within 1 week of injury.

Trial details

NCT IDNCT05964764

SponsorHalmstad County Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-08-31

Contact for this trial

Fredrik Wickbom, MD

004635131000 fredrik.wickbom@regionhalland.se

View on ClinicalTrials.gov More Brain Injuries, Traumatic trials