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

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

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
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.

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

Groups and Cohorts

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

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 [ Time Frame: one month ]

Eligibility Criteria

• 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.

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

Contacts and Locations

Locations

France

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

Investigators

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

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lorton F, Poullaouec C, Legallais E, Simon-Pimmel J, Chene MA, Leroy H, Roy M, Launay E, Gras-Le Guen C. Validation of the PECARN clinical decision rule for children with minor head trauma: a French multicenter prospective study. Scand J Trauma Resusc Emerg Med. 2016 Aug 4;24:98. doi: 10.1186/s13049-016-0287-3.

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT02752711
• Other Study ID Numbers: RC13_0111
• First Posted: April 27, 2016
• 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; Children; Clinical decision rule

Additional relevant MeSH terms:

Craniocerebral Trauma; Wounds and Injuries; Trauma, Nervous System; Nervous System Diseases