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

Head Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02752711
• Other study ID #: RC13_0111
• Status: Completed
• Phase: N/A
• First received: April 22, 2016
• Last updated: April 28, 2016
• Start date: May 2013
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1499
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Head Injury

Intervention

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

Locations

Country	Name	City	State
France	Departmental Hospital of Vendée	La Roche Sur Yon
France	Nantes University Hospital	Nantes
France	Hospital of Saint-Nazaire	Saint Nazaire

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

Kuppermann N, Holmes JF, Dayan PS, Hoyle JD Jr, Atabaki SM, Holubkov R, Nadel FM, Monroe D, Stanley RM, Borgialli DA, Badawy MK, Schunk JE, Quayle KS, Mahajan P, Lichenstein R, Lillis KA, Tunik MG, Jacobs ES, Callahan JM, Gorelick MH, Glass TF, Lee LK, Bachman MC, Cooper A, Powell EC, Gerardi MJ, Melville KA, Muizelaar JP, Wisner DH, Zuspan SJ, Dean JM, Wootton-Gorges SL; Pediatric Emergency Care Applied Research Network (PECARN). Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study. Lancet. 2009 Oct 3;374(9696):1160-70. doi: 10.1016/S0140-6736(09)61558-0. Epub 2009 Sep 14. Erratum in: Lancet. 2014 Jan 25;383(9914):308. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No