NCT02357186

Broad Validation Study of a Management Algorithm Mild Head Injury in Children

Multicenter Prospective Broad Validation of a Management Algorithm Mild Head Injury in Children

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7,871 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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 Rule Clinical Decision is adapted or not to the management of mild head injuries in the French pediatric population.

Conditions

• Head Injury

Timeline

• Start date: 2015-11-16
• Primary completion: 2018-08-01
• Completion: 2018-09-01
• First posted: 2015-02-06
• Last updated: 2018-12-12

Locations

9 sites across 1 country: France