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
St. Justine's Hospital
Information provided by (Responsible Party):
Laurence Ducharme-Crevier, St. Justine's Hospital
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective cohort study|
|Masking:||None (Open Label)|
|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|
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 :
- 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 :
- 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
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