CompletedNot Applicable

Infant Minor Head Trauma Clinical Decision Rule

France8,802 participantsStarted 2017-02-11

Plain-language summary

The purpose of this study is to validate a clinical decision rule for the management of minor head trauma in infants aged less than two years, constructed with the intention of minimizing the rate of computed tomography scans ordering.

Who can participate

Age range

2 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: * Child aged less than 2 years presenting to pediatric emergencies for evaluation within 24 hours of an apparently minor blunt head trauma, defined by a pediatric Glasgow coma scale score of 14 or 15 at initial clinical assessment * Non opposition from parents to their child inclusion and collect of these data * Child with social insurance Exclusion Criteria: * Trivial head injury * Neurosurgical history * Pre-existing neurological disorder * Bleeding disorder * Suspected child abuse * Open fracture * Penetrating skull injury * Polytrauma and substantial non cranial serious injury * Isolated facial trauma * Imaging performed before ED visit * Prior inclusion of the child in the study

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

Presence of a clinically-important traumatic brain injuries (ciTBI)

Timeframe: 7 days after head trauma

Trial details

NCT IDNCT03050970

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-09-17

View on ClinicalTrials.gov More Head Trauma trials

Who can participate

Age range

2 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.