Infant Minor Head Trauma Clinical Decision Rule (PELICAN)

December 3, 2020 updated by: Assistance Publique - Hôpitaux de Paris

Performance of a Minor Head Trauma Clinical Decision Rule Dedicated to Children Younger Than Two Years: A National Prospective Multicenter Study

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Apparently minor head trauma (MHT), defined by a Glasgow coma scale score (GCS) of 14-15, is the most frequently assessed group among the population of children attending Emergency Department (ED) for head trauma. Less than 1% of children with MHT have a clinically important traumatic brain injury (ciTBI) that is requiring immediate and specific care, especially neurosurgery. Those ciTBI should be identified rapidly. Assessment of children < 2 years is particularly difficult. This may promote excessive computed tomography (CT) scans ordering in this age group, while the youngest are the most sensitive to the risk of secondary malignity induced by ionizing radiation from CT scan. In USA, 31% of children < 2 years with MHT undergo CT scan. Data for CT scan use in France are unavailable and subjected to practice variations. The predictive values of TBI clinical variables such as vomiting, immediate loss of consciousness, impact seizure, severe injury mechanism, scalp hematoma or skull fracture, are controversial. A short clinical observation of children with such signs or post-traumatic symptoms before making the decision regarding CT scan ordering seems to be beneficial, allowing selective CT scan use for children whose symptoms fail to resolve. To improve patient care, clinical decision rules attempting to risk-stratify the need for a scan have emerged in the literature.

Age-based PECARN rule derived and validated in the larger cohort of 10 718 children < 2 years is the reference in the management of minor head trauma. The PECARN rule identifies ciTBIs with an optimal sensitivity but with a high rate of normal scans or identifying a non-significant lesion (expected CT scans rate: 23%; ciTBI: 0,85%). This North American rule is recommended by the Emergency Medicine French Society for the management of minor head injury. This study aims to evaluate the performance of the PELICAN rule, a decision rule for the management of apparently minor head trauma in children < 2 years that proposes targeted indications for CT scan use and defines precise indications for clinical observation. The PELICAN rule was built after a literature review of the predictive values of TBI clinical variables with the intention of minimizing the CT scans rate without missing any ciTBI.

The primary objective is to assess the performance of the PELICAN clinical prediction rule for identifying clinical-important traumatic brain injuries after apparently minor head trauma (GCS 14-15) in infants less than 2 years. The performance of the PECARN TBI prediction rule when applied to a large national French population will also be assisted and compared to that of PELICAN rule in terms of security, efficacy and expected impact on CT ordering.

Study Type

Observational

Enrollment (Actual)

8802

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Pediatric Emergency Department - Necker-Enfants malades Hospital -

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infants aged less than two years attending at emergency departments

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of a clinically-important traumatic brain injuries (ciTBI)
Time Frame: 7 days after head trauma
Clinically-important traumatic brain injury defined by: death, intubation > 24h, neurosurgical intervention and/or admission > 2 nights for head injury with traumatic brain injury on CT scan
7 days after head trauma

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of CT scans that would be recommended by the PELICAN rule applied in the study population
Time Frame: Initial emergency clinical evaluation
Assessment of the number of children with any of the PELICAN predictive variables recommending CT scan ordering
Initial emergency clinical evaluation
Rate of CT scans that would be recommended by the PELICAN rule applied in the study population
Time Frame: 24 hours following the initial evaluation
Assessment of the number of children with any of the PELICAN predictive variables recommending CT scan ordering
24 hours following the initial evaluation
Number of patients with any of the six predictive variables of PECARN rule and classification in each risk-level group
Time Frame: Initial emergency clinical evaluation
Performance of the age-based PECARN TBI prediction rule for identifying ciTBI
Initial emergency clinical evaluation
Number of patients with TBI on CT undergoing neurosurgery
Time Frame: 7 days after head trauma
TBI outcomes of children < 2 years
7 days after head trauma
Rate of CT scan use in practice
Time Frame: 7 days after head trauma
to analyse the different management care strategies applied to a large national French observational study population
7 days after head trauma
Number of patients with a non-clinically significant TBI identified on CT scan who would have been missed by the PELICAN rule
Time Frame: 7 days after head trauma

Presence of a TBI on CT scan that doesn't result in death, intubation < 24h, neurosurgery and/or admission over 2 nights, in a patient who had no PELICAN predictors recommending CT scan.

Presence in these patients of post-traumatic signs or symptoms requiring admission or any specific therapy
7 days after head trauma
Rate of Admission for short ED clinical observation expected by the application of PELICAN rule
Time Frame: 24 hours after head trauma
Presence of a PELICAN variable recommending short clinical observation
24 hours after head trauma

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Francophone Pediatric Resuscitation and Emergency Group (GFRUP)

Investigators

  • Study Chair: Gérard CHERON, MD, PhD, Assistance Publique - Hôpitaux de Paris
  • Principal Investigator: Géraldine PATTEAU, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2017

Primary Completion (Actual)

September 17, 2019

Study Completion (Actual)

September 17, 2019

Study Registration Dates

First Submitted

January 31, 2017

First Submitted That Met QC Criteria

February 8, 2017

First Posted (Actual)

February 13, 2017

Study Record Updates

Last Update Posted (Actual)

December 4, 2020

Last Update Submitted That Met QC Criteria

December 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A00629-42
  • NI 15019 - AOM 15311 (Other Identifier: Assistance-Publique Hôpitaux de Paris)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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