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Infant Minor Head Trauma Clinical Decision Rule (PELICAN)

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ClinicalTrials.gov Identifier: NCT03050970
Recruitment Status : Unknown
Verified April 2018 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : February 13, 2017
Last Update Posted : April 30, 2018
Sponsor:
Collaborator:
Francophone Pediatric Resuscitation and Emergency Group (GFRUP)
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The purpose of this study is to validate a clinical decision rule for the management of minor head trauma in infants aged less than two years, constructed with the intention of minimizing the rate of computed tomography scans ordering.

Condition or disease
Head Trauma

Detailed Description:

Apparently minor head trauma (MHT), defined by a Glasgow coma scale score (GCS) of 14-15, is the most frequently assessed group among the population of children attending Emergency Department (ED) for head trauma. Less than 1% of children with MHT have a clinically important traumatic brain injury (ciTBI) that is requiring immediate and specific care, especially neurosurgery. Those ciTBI should be identified rapidly. Assessment of children < 2 years is particularly difficult. This may promote excessive computed tomography (CT) scans ordering in this age group, while the youngest are the most sensitive to the risk of secondary malignity induced by ionizing radiation from CT scan. In USA, 31% of children < 2 years with MHT undergo CT scan. Data for CT scan use in France are unavailable and subjected to practice variations. The predictive values of TBI clinical variables such as vomiting, immediate loss of consciousness, impact seizure, severe injury mechanism, scalp hematoma or skull fracture, are controversial. A short clinical observation of children with such signs or post-traumatic symptoms before making the decision regarding CT scan ordering seems to be beneficial, allowing selective CT scan use for children whose symptoms fail to resolve. To improve patient care, clinical decision rules attempting to risk-stratify the need for a scan have emerged in the literature.

Age-based PECARN rule derived and validated in the larger cohort of 10 718 children < 2 years is the reference in the management of minor head trauma. The PECARN rule identifies ciTBIs with an optimal sensitivity but with a high rate of normal scans or identifying a non-significant lesion (expected CT scans rate: 23%; ciTBI: 0,85%). This North American rule is recommended by the Emergency Medicine French Society for the management of minor head injury. This study aims to evaluate the performance of the PELICAN rule, a decision rule for the management of apparently minor head trauma in children < 2 years that proposes targeted indications for CT scan use and defines precise indications for clinical observation. The PELICAN rule was built after a literature review of the predictive values of TBI clinical variables with the intention of minimizing the CT scans rate without missing any ciTBI.

The primary objective is to assess the performance of the PELICAN clinical prediction rule for identifying clinical-important traumatic brain injuries after apparently minor head trauma (GCS 14-15) in infants less than 2 years. The performance of the PECARN TBI prediction rule when applied to a large national French population will also be assisted and compared to that of PELICAN rule in terms of security, efficacy and expected impact on CT ordering.

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Performance of a Minor Head Trauma Clinical Decision Rule Dedicated to Children Younger Than Two Years: A National Prospective Multicenter Study
Actual Study Start Date : February 11, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Presence of a clinically-important traumatic brain injuries (ciTBI) [ Time Frame: 7 days after head trauma ]
    Clinically-important traumatic brain injury defined by: death, intubation > 24h, neurosurgical intervention and/or admission > 2 nights for head injury with traumatic brain injury on CT scan


Secondary Outcome Measures :
  1. Rate of CT scans that would be recommended by the PELICAN rule applied in the study population [ Time Frame: Initial emergency clinical evaluation ]
    Assessment of the number of children with any of the PELICAN predictive variables recommending CT scan ordering

  2. Rate of CT scans that would be recommended by the PELICAN rule applied in the study population [ Time Frame: 24 hours following the initial evaluation ]
    Assessment of the number of children with any of the PELICAN predictive variables recommending CT scan ordering

  3. Number of patients with any of the six predictive variables of PECARN rule and classification in each risk-level group [ Time Frame: Initial emergency clinical evaluation ]
    Performance of the age-based PECARN TBI prediction rule for identifying ciTBI

  4. Number of patients with TBI on CT undergoing neurosurgery [ Time Frame: 7 days after head trauma ]
    TBI outcomes of children < 2 years

  5. Rate of CT scan use in practice [ Time Frame: 7 days after head trauma ]
    to analyse the different management care strategies applied to a large national French observational study population

  6. Number of patients with a non-clinically significant TBI identified on CT scan who would have been missed by the PELICAN rule [ Time Frame: 7 days after head trauma ]

    Presence of a TBI on CT scan that doesn't result in death, intubation < 24h, neurosurgery and/or admission over 2 nights, in a patient who had no PELICAN predictors recommending CT scan.

    Presence in these patients of post-traumatic signs or symptoms requiring admission or any specific therapy


  7. Rate of Admission for short ED clinical observation expected by the application of PELICAN rule [ Time Frame: 24 hours after head trauma ]
    Presence of a PELICAN variable recommending short clinical observation



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants aged less than two years attending at emergency departments
Criteria

Inclusion Criteria:

  • Child aged less than 2 years presenting to pediatric emergencies for evaluation within 24 hours of an apparently minor blunt head trauma, defined by a pediatric Glasgow coma scale score of 14 or 15 at initial clinical assessment
  • Non opposition from parents to their child inclusion and collect of these data
  • Child with social insurance

Exclusion Criteria:

  • Trivial head injury
  • Neurosurgical history
  • Pre-existing neurological disorder
  • Bleeding disorder
  • Suspected child abuse
  • Open fracture
  • Penetrating skull injury
  • Polytrauma and substantial non cranial serious injury
  • Isolated facial trauma
  • Imaging performed before ED visit
  • Prior inclusion of the child in the study

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): NCT03050970


Contacts
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Contact: Géraldine PATTEAU, MD +33 (0)1 71 39 68 36 geraldine.patteau@aphp.fr
Contact: Prissile BAKOUBOULA, PhD +33 (0)1 71 19 64 94 prissile.bakouboula@aphp.fr

Locations
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France
Pediatric Emergency Department - Necker-Enfants malades Hospital - Recruiting
Paris, France, 75015
Contact: géraldine PATTEAU, MD    +33 (0)1 71 39 68 36    geraldine.patteau@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Francophone Pediatric Resuscitation and Emergency Group (GFRUP)
Investigators
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Study Chair: Gérard CHERON, MD, PhD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Géraldine PATTEAU, MD Assistance Publique - Hôpitaux de Paris
Publications:
Jehlé E, Honnart D, Grasleguen C, et al. Comité de pilotage. Minor head injury (Glasgow Coma Score 13 to 15): triage, assessment, investigation and early management of minor head injury in infants, children and adults. Ann Fr Med Urg 2012;2:199-214

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03050970    
Other Study ID Numbers: 2016-A00629-42
NI 15019 - AOM 15311 ( Other Identifier: Assistance-Publique Hôpitaux de Paris )
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
minor head trauma
child
age less than 2 years
Clinically-important traumatic brain injury (ciTBI)
Computed tomography scan
Radiation exposure from CT scans
Additional relevant MeSH terms:
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Craniocerebral Trauma
Wounds and Injuries
Trauma, Nervous System
Nervous System Diseases