Infant Minor Head Trauma Clinical Decision Rule

Study Overview
=================
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.

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

Conditions
-----------------
Head Trauma

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Maximum Age: 2 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of a clinically-important traumatic brain injuries (ciTBI) | 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 | 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 | 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 | 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 | TBI outcomes of children < 2 years | 7 days after head trauma | 
| Rate of CT scan use in practice | 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 | 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 | Presence of a PELICAN variable recommending short clinical observation | 24 hours after head trauma | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
minor head trauma, child, age less than 2 years, Clinically-important traumatic brain injury (ciTBI), Computed tomography scan, Radiation exposure from CT scans