NCT02752711

Validation of the PECARN Clinical Decision Rule for Children With Minor Head Trauma

Validation of the PECARN Clinical Decision Rule for Children With Minor Head Trauma: a French Multicenter Prospective Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,499 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

To date, the Pediatric Emergency Care Applied Research Network (PECARN) rule for identifying children who are at very low risk of clinically-important traumatic brain injuries after minor head trauma has not been validated prospectively in an independent population. Our goal was to evaluate the diagnostic performance of the PECARN clinical decision rule in a French pediatric population in multiple clinical settings.

Detailed description

Head injury is a frequent reason for consultation with pediatric emergencies, over 95% are mild head injury defined by a Glasgow score greater than or equal to 13. In October 2009, the Pediatric Emergency Care Applied Research Network has published a rule clinical decision support of mild head injury of the child with the aim to identify children at very low risk for clinically severe intracranial lesions in order to avoid the use of CT and unnecessary exposure to radiation ionizing. This clinical decision rule constructed from a multicenter prospective cohort 42,412 American children allows on anamnestic and clinical elements to guide medical decision for conducting brain imaging, hospital monitoring or discharge home placing the child in three levels of risk of clinically severe intracranial lesions. Since March 2012, the French Emergency Medicine Society recommends for the treatment of mild head trauma the child's use of the clinical decision rule provided that it is the subject of a validation study externally. Indeed, after the construction phase and before its daily application, a clinical decision rule must be subject to an broad validation process so that its predictive performance can be definitively established. The investigators' work aims to conduct this broad validation study prospective multicenter way in a French pediatric population, as recommended by the French Emergency Medicine Society, in order to confirm or deny its predictive performance and allow its application and generalization. The investigators will check and if the clinical decision rule is adapted or not to the management of mild head injuries in the French pediatric population.

Conditions

• Head Injury

Interventions

Type	Name	Description
PROCEDURE	the PECARN clinical decision rule	the PECARN clinical decision rule for the detection of clinically-important traumatic brain injuries in children with minor head trauma

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-10-01
• Completion: 2015-12-01
• First posted: 2016-04-27
• Last updated: 2016-05-02

Locations

3 sites across 1 country: France