Traumatic Brain Injury
Conditions
Keywords
outcome, paediatric critical care
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.
Interventions
DIAGNOSTIC_TESTPrognostication 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.
Sponsors
St. Justine's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective cohort study
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association with poor neurological outcome | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | In the 72 hours following TBI | Adverse events will be defined as increased intracranial pressure, decreased cerebral perfusion pressure, seizure or cardiac arrest |
Outcome results
None listed