Broad Validation Study of a Management Algorithm Mild Head Injury in Children

NCT02357186 | Completed

• 1 other identifier: RC15_0038
• Study Type: observational
• Target: 7,871
• Locations: 1 country
• Sites: 9

Brief Summary

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 Rule Clinical Decision is adapted or not to the management of mild head injuries in the French pediatric population.

Conditions

Head Injury

Keywords

Mild head injury - clinical decision rule - Child

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

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Will be included in the study 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. The mild head injury is usually defined by a GCS ≥ 13, but the study of the Pediatric Emergency Care Applied Research Network was interested in the population of children with TBI Glasgow score was greater than or equal to 14. Indeed the care of children with head trauma with a Glasgow score below 14 is not controversial. The risk of traumatic brain injury is at least 20%, achieving a brain scan is routinely recommended for these children. The investigators will resume the same characteristics for the study population as the study of the Pediatric Emergency Care Applied Research Network.

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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (9)

Angers University Hospital

Angers, 49933, France

Location

Brest University Hospital

Brest, 29609, France

Location

Centre Hospiatlier Départemental de Vendée

La Roche-sur-Yon, 85925, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

Poitiers University Hospital

Poitiers, 86021, France

Location

Rennes University Hospital

Rennes, 35203, France

Location

Saint-Nazaire Hospital

Saint-Nazaire, 44606, France

Location

Toulouse University Hospital

Toulouse, 31000, France

Location

Tours University Hospital

Tours, 37044, France

Location

MeSH Terms

Conditions

Craniocerebral Trauma

Condition Hierarchy (Ancestors)

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

Study Officials

• Fleur Lorton, Dr

  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: January 21, 2015
• First Posted: February 6, 2015
• Study Start: November 16, 2015
• Primary Completion: August 1, 2018
• Study Completion: September 1, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

FR (9)