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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04157634
Other study ID # HSJ - 2020-2526
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2020
Est. completion date December 2022

Study information

Verified date November 2019
Source St. Justine's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date December 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
St. Justine's Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Association with poor neurological outcome A poor neurological outcome will be defined as on death or neurocognitive dysfunction in survivors We will assess neurocognitive function of patients at 6 ±2 months following the discharge from the Pediatric Intensive Care Unit
Secondary Adverse events Adverse events will be defined as increased intracranial pressure, decreased cerebral perfusion pressure, seizure or cardiac arrest In the 72 hours following TBI
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