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

NCT ID: NCT02357186

Last Updated: 2018-12-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7871 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-16
• Study Completion Date: 2018-09-30

Brief 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

Keywords

Mild head injury - clinical decision rule - Child

Study Design

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

Eligibility Criteria

Inclusion Criteria

• Children under 16 years admitted to an emergency room for mild head injury (Glasgow Coma Scale score ≥14) in the previous 24 hours
• Children who have agreed to participate in the study (if age> 8 years)
• Patient Parents have accepted the participation of their child in the study

Exclusion Criteria

• Children with bleeding disorders
• Ventricular shunt Presence
• Benin mechanism of trauma (fall of the height of the child or impact against an object while walking / running with no sign that the scalp dermabrasion)
• Penetrating trauma
• Known brain tumor
• Previously known neurological disorders
• Evaluation scanographic in another hospital before emergency review

• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fleur Lorton, Dr

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

Angers University Hospital

Angers, , France

Brest University Hospital

Brest, , France

Centre Hospiatlier Départemental de Vendée

La Roche-sur-Yon, , France

Nantes University Hospital

Nantes, , France

Poitiers University Hospital

Poitiers, , France

Rennes University Hospital

Rennes, , France

Saint-Nazaire Hospital

Saint-Nazaire, , France

Toulouse University Hospital

Toulouse, , France

Tours University Hospital

Tours, , France

Countries

France

Other Identifiers

RC15_0038

Identifier Type: -

Identifier Source: org_study_id