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New rule could spare thousands of infants from unnecessary brain scans

NCT ID NCT03050970

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at over 8,800 infants under 2 years old who came to the emergency room with a minor head injury. Researchers wanted to see if a special checklist (the PELICAN rule) could help doctors decide when a CT scan is truly needed. The goal is to avoid unnecessary radiation in young children while still catching any serious brain injuries.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could give doctors a reliable tool to decide which infants need a CT scan after a minor head bump, reducing unnecessary radiation exposure.
What could go wrong
This is an observational study, not a treatment trial. The rule may not work perfectly in all settings, and some serious injuries could still be missed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

8,802 people

The number who actually took part.

Started

Feb 2017

Finished

Sep 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Infants aged less than two years attending at emergency departments

Ages

Up to 2 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Craniocerebral Trauma head injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head trauma

Contacts and locations

Locations

  • Pediatric Emergency Department - Necker-Enfants malades Hospital -

    Paris, Paris, 75015, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.