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

Sponsor
Nantes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02752711
Collaborator
(none)
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: the PECARN clinical decision rule

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.

Study Design

Study Type:
Observational
Actual Enrollment :
1499 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Validation of the PECARN Clinical Decision Rule for Children With Minor Head Trauma: a French Multicenter Prospective Study
Study Start Date :
May 1, 2013
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Outcome Measures

Primary Outcome Measures

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Departmental Hospital of Vendée La Roche Sur Yon France 85925
2 Nantes University Hospital Nantes France 44093
3 Hospital of Saint-Nazaire Saint Nazaire France 44606

Sponsors and Collaborators

  • Nantes University Hospital

Investigators

  • Principal Investigator: Fleur LORTON, MD, Nantes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT02752711
Other Study ID Numbers:
  • RC13_0111
First Posted:
Apr 27, 2016
Last Update Posted:
May 2, 2016
Last Verified:
Apr 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Nantes University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 2, 2016