Infant Minor Head Trauma Clinical Decision Rule

NCT ID: NCT03050970

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8802 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-11
• Study Completion Date: 2019-09-17

Brief 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.

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.

Conditions

Head Trauma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Francophone Pediatric Resuscitation and Emergency Group (GFRUP)

OTHER

Sponsor Role: collaborator

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gérard CHERON, MD, PhD

Role: STUDY_CHAIR

Assistance Publique - Hôpitaux de Paris

Géraldine PATTEAU, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Pediatric Emergency Department - Necker-Enfants malades Hospital -

Paris, Paris, France

Countries

France

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Other Identifiers

NI 15019 - AOM 15311

Identifier Type: OTHER

Identifier Source: secondary_id

2016-A00629-42

Identifier Type: -

Identifier Source: org_study_id