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Prediction of Neurological Outcome of Children After a Traumatic Brain Injury Based on an Integrated Predictive Model

Primary Purpose

Traumatic Brain Injury

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prognostication model
Sponsored by
St. Justine's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Traumatic Brain Injury focused on measuring outcome, paediatric critical care

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Children 1) <18 years; 2) admitted to the Paediatric Intensive Care Unit at the Centre Hospitalier Universitaire Ste-Justine; 3) moderate (Glasgow Coma Scale (GCS): 9-12) or severe TBI (GCS ≤8), assessed after initial resuscitation; 4) admitted to the Paediatric Intensive Care Unit less than 24 hours after the initial TBI and 5) written parental consent. Patients with either inflicted or accidental TBI will be included as they characterize different but important population, our model should be valuable for both.

Exclusion Criteria:

Children 1) suspected of being brain death at the time of Paediatric Intensive Care Unit entry (GCS 3 and loss of all brain stem reflexes); 2) with a pacemaker (HRV monitoring unreliable); and/or 3) patients or parents who do not speak or read English or French.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Prognostication model

    Arm Description

    In a prospective cohort of children hospitalized in a PICU, development of a model based on biomarkers, HRV, and a computerized classifier output, to predict long-term neurological outcome after a moderate or severe TBI in children aged 0 to 18 years.

    Outcomes

    Primary Outcome Measures

    Association with poor neurological outcome
    A poor neurological outcome will be defined as on death or neurocognitive dysfunction in survivors

    Secondary Outcome Measures

    Adverse events
    Adverse events will be defined as increased intracranial pressure, decreased cerebral perfusion pressure, seizure or cardiac arrest

    Full Information

    First Posted
    November 6, 2019
    Last Updated
    November 7, 2019
    Sponsor
    St. Justine's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04157634
    Brief Title
    Prediction of Neurological Outcome of Children After a Traumatic Brain Injury Based on an Integrated Predictive Model
    Official Title
    Prediction of Neurological Outcome of Children After a Moderate or Severe Traumatic Brain Injury, Based on an Integrated Predictive Model (Serum Biomarkers, Heart Rate Variability, Computerized Classifier Output)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2020 (Anticipated)
    Primary Completion Date
    December 2021 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    St. Justine's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study aims to develop a integrated predictive model based on serum biomarkers, HRV, and an innovative computerized classifier output, to predict the patient long term neurological outcome after a moderate or severe TBI in children.
    Detailed Description
    Traumatic brain injury (TBI) is a major cause of morbidity and mortality in children. Most children with moderate and severe TBI have long term sequelae including neurological deficit, cognitive impairment and behavioural disorders. In the acute care setting, neither clinicians nor researchers are able to adequately predict the long term outcome of children with TBI, consequently limiting their ability to tailor medical care, rehabilitation and support services. Improving our understanding of a TBI patient's exact cerebral status and prognosis is a critical step toward optimized and personalized patient management. In this research study, an innovative and integrated model will be developed to improve the prognostication in the early phase of a TBI. This model will combine key clinical variables commonly collected in the acute care setting and combine these with cutting-edge empirical measures: 1) biomarkers; 2) a new physiological monitoring based on heart-rate variability (HRV) to assess the integrity of the autonomic system; and 3) a computerized classification tool developed using the concept of artificial intelligence to continuously categorize the patient's cerebral status.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Traumatic Brain Injury
    Keywords
    outcome, paediatric critical care

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Prospective cohort study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Prognostication model
    Arm Type
    Experimental
    Arm Description
    In a prospective cohort of children hospitalized in a PICU, development of a model based on biomarkers, HRV, and a computerized classifier output, to predict long-term neurological outcome after a moderate or severe TBI in children aged 0 to 18 years.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Prognostication model
    Intervention Description
    In a prospective cohort of children hospitalized in a PICU, developement a model based on biomarkers, HRV, and a computerized classifier output, to predict long-term neurological outcome after a moderate or severe TBI in children aged 0 to 18 years.
    Primary Outcome Measure Information:
    Title
    Association with poor neurological outcome
    Description
    A poor neurological outcome will be defined as on death or neurocognitive dysfunction in survivors
    Time Frame
    We will assess neurocognitive function of patients at 6 ±2 months following the discharge from the Pediatric Intensive Care Unit
    Secondary Outcome Measure Information:
    Title
    Adverse events
    Description
    Adverse events will be defined as increased intracranial pressure, decreased cerebral perfusion pressure, seizure or cardiac arrest
    Time Frame
    In the 72 hours following TBI

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children 1) <18 years; 2) admitted to the Paediatric Intensive Care Unit at the Centre Hospitalier Universitaire Ste-Justine; 3) moderate (Glasgow Coma Scale (GCS): 9-12) or severe TBI (GCS ≤8), assessed after initial resuscitation; 4) admitted to the Paediatric Intensive Care Unit less than 24 hours after the initial TBI and 5) written parental consent. Patients with either inflicted or accidental TBI will be included as they characterize different but important population, our model should be valuable for both. Exclusion Criteria: Children 1) suspected of being brain death at the time of Paediatric Intensive Care Unit entry (GCS 3 and loss of all brain stem reflexes); 2) with a pacemaker (HRV monitoring unreliable); and/or 3) patients or parents who do not speak or read English or French.

    12. IPD Sharing Statement

    Learn more about this trial

    Prediction of Neurological Outcome of Children After a Traumatic Brain Injury Based on an Integrated Predictive Model

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