NCT02752711

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,499

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 27, 2016

Completed
Last Updated

May 2, 2016

Status Verified

April 1, 2016

Enrollment Period

2.4 years

First QC Date

April 22, 2016

Last Update Submit

April 28, 2016

Conditions

Head Injury

Keywords

Minor head traumaChildrenClinical decision rule

Outcome Measures

Primary Outcomes (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

Interventions

the PECARN clinical decision rulePROCEDURE

the PECARN clinical decision rule for the detection of clinically-important traumatic brain injuries in children with minor head trauma

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Departmental Hospital of Vendée

La Roche-sur-Yon, 85925, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

Hospital of Saint-Nazaire

Saint-Nazaire, 44606, France

Location

Related Publications (2)

  • 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.

    PMID: 19758692BACKGROUND

  • 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.

    PMID: 27488722DERIVED

MeSH Terms

Conditions

Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and Injuries

Study Officials

  • Fleur LORTON, MD

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2016

First Posted

April 27, 2016

Study Start

May 1, 2013

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

May 2, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)