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Trial record 1 of 1 for:    NCT02752711
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Validation of the PECARN Clinical Decision Rule for Children With Minor Head Trauma

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ClinicalTrials.gov Identifier: NCT02752711
Recruitment Status : Completed
First Posted : April 27, 2016
Last Update Posted : May 2, 2016
Information provided by (Responsible Party):
Nantes University Hospital

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
Head Injury 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.

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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 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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

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 [ Time Frame: one month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
In the study we included all children under 16 years of age admitted to the emergency room with mild head trauma with a Glasgow score greater than or equal to 14, occurred in the previous 24 hours.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02752711

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Departmental Hospital of Vendée
La Roche Sur Yon, France, 85925
Nantes University Hospital
Nantes, France, 44093
Hospital of Saint-Nazaire
Saint Nazaire, France, 44606
Sponsors and Collaborators
Nantes University Hospital
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Principal Investigator: Fleur LORTON, MD Nantes University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02752711    
Other Study ID Numbers: RC13_0111
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: May 2, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nantes University Hospital:
Minor head trauma
Clinical decision rule
Additional relevant MeSH terms:
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Craniocerebral Trauma
Wounds and Injuries
Trauma, Nervous System
Nervous System Diseases