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

NCT04157634 | Unknown

• 1 other identifier: HSJ - 2020-2526
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Traumatic Brain Injury

Keywords

outcome; paediatric critical care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse events

  In the 72 hours following TBI

Study Arms (1)

Prognostication model

EXPERIMENTAL

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

Interventions

Prognostication model DIAGNOSTIC_TEST

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.

Prognostication model

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Justine's Hospital: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Paediatric Intensivist

Model Details: Prospective cohort study

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: January 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: November 8, 2019

Record last verified: 2019-11