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

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ClinicalTrials.gov Identifier: NCT04157634
Recruitment Status : Not yet recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Laurence Ducharme-Crevier, St. Justine's Hospital

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Diagnostic Test: Prognostication model Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective cohort study
Masking: None (Open Label)
Primary Purpose: Other
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)
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prognostication model
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.
Diagnostic Test: Prognostication model
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 Measures :
  1. Association with poor neurological outcome [ Time Frame: We will assess neurocognitive function of patients at 6 ±2 months following the discharge from the Pediatric Intensive Care Unit ]
    A poor neurological outcome will be defined as on death or neurocognitive dysfunction in survivors


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: In the 72 hours following TBI ]
    Adverse events will be defined as increased intracranial pressure, decreased cerebral perfusion pressure, seizure or cardiac arrest



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


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Responsible Party: Laurence Ducharme-Crevier, Paediatric Intensivist, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT04157634     History of Changes
Other Study ID Numbers: HSJ - 2020-2526
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019

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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 Laurence Ducharme-Crevier, St. Justine's Hospital:
outcome
paediatric critical care
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System