Clinical trial NCT03050970: Infant Minor Head Trauma Clinical Decision Rule
Official title: Performance of a Minor Head Trauma Clinical Decision Rule Dedicated to Children Younger Than Two Years: A National Prospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head Trauma
Keywords: minor head trauma
child
age less than 2 years
Clinically-important traumatic brain injury (ciTBI)
Computed tomography scan
Radiation exposure from CT scans
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Francophone Pediatric Resuscitation and Emergency Group (GFRUP)
First posted: 2017-02-13
Enrollment: 8802
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants aged less than two years attending at emergency departments

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.

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

Primary outcomes:
measure: Presence of a clinically-important traumatic brain injuries (ciTBI)
timeFrame: 7 days after head trauma
Secondary outcomes:
measure: Rate of CT scans that would be recommended by the PELICAN rule applied in the study population
timeFrame: Initial emergency clinical evaluation
measure: Rate of CT scans that would be recommended by the PELICAN rule applied in the study population
timeFrame: 24 hours following the initial evaluation
measure: Number of patients with any of the six predictive variables of PECARN rule and classification in each risk-level group
timeFrame: Initial emergency clinical evaluation
measure: Number of patients with TBI on CT undergoing neurosurgery
timeFrame: 7 days after head trauma
measure: Rate of CT scan use in practice
timeFrame: 7 days after head trauma
measure: Number of patients with a non-clinically significant TBI identified on CT scan who would have been missed by the PELICAN rule
timeFrame: 7 days after head trauma
measure: Rate of Admission for short ED clinical observation expected by the application of PELICAN rule
timeFrame: 24 hours after head trauma
Other outcomes:
Locations:
city: Paris
country: France
facility: Pediatric Emergency Department - Necker-Enfants malades Hospital -
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Gérard CHERON, MD, PhD
role: STUDY_CHAIR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Géraldine PATTEAU, MD
role: PRINCIPAL_INVESTIGATOR
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