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

Completed

• Conditions: Head Injury

• Registration Number: NCT02357186
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-21
• Study First Submitted QC: 2015-02-05
• Study First Posted: 2015-02-06
• Study Start: 2015-11-16
• Primary Completion: 2018-08
• Study Completion: 2018-09
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7871

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with clinically severe intracranial injury and classified at risk (top and middle) according to clinical decision rule in all patients with severe intracranial lesions.	one month

Trial Locations

Locations (9)

Angers University Hospital; 🇫🇷 Angers, France

Toulouse University Hospital; 🇫🇷 Toulouse, France

Centre Hospiatlier Départemental de Vendée; 🇫🇷 La Roche sur Yon, France

Poitiers University Hospital; 🇫🇷 Poitiers, France

Brest University Hospital; 🇫🇷 Brest, France

Rennes University Hospital; 🇫🇷 Rennes, France

Saint-Nazaire Hospital; 🇫🇷 Saint-Nazaire, France

Nantes University Hospital; 🇫🇷 Nantes, France

Tours University Hospital; 🇫🇷 Tours, France