Validation of the PECARN Clinical Decision Rule for Children With Minor Head Trauma
NCT ID: NCT02752711
Last Updated: 2016-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1499 participants
OBSERVATIONAL
2013-05-31
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Broad Validation Study of a Management Algorithm Mild Head Injury in Children
NCT02357186
Traumatic Brain Injury - Knowledge Translation
NCT01453621
Infant Minor Head Trauma Clinical Decision Rule
NCT03050970
PECARN Versus NICE Guidelines for Pediatric Head Trauma in Emergency Department in Assuit and Sohag University Hospitals
NCT06768710
Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury
NCT02819778
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nantes University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fleur LORTON, MD
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Departmental Hospital of Vendée
La Roche-sur-Yon, , France
Nantes University Hospital
Nantes, , France
Hospital of Saint-Nazaire
Saint-Nazaire, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RC13_0111
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.