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OpenTrials
Completed

NCT Number: NCT03701620

Heart Rate Variability in Children With Traumatic Brain Injury

Using a prospective cohort of children admitted to the PICU, the investigators will determine HRV monitoring is feasible, if a decreased HRV in the 7 days following moderate or severe TBI in children is associated with a worse outcome 6 months post-TBI and investigate HRV as a tool that can predict adverse events (neurological crisis) within 2 days following TBI.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Child Development Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

About this study

This is a single center prospective cohort study of 15 children <18 years, admitted to the PICU at the CHU Sainte-Justine (CHUSJ) with moderate or severe TBI (<24 hours). Neurodevelopment outcome of children will be evaluated 6 months post TBI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • <18 years
  • admitted to the PICU at the CHUSJ
  • moderate TBI (Glasgow Coma Scale (GCS): 9-12) or severe TBI (GCS ≤8) as - - assessed 30 minutes after TBI or upon arrival in the emergency room
  • written parental consent.

Exclusion criteria

  • children fulfilling brain death criteria at the time of PICU admission (GCS 3 and loss of all brain stem reflexes)
  • children with a pacemaker or with previously diagnosed arrhythmia (HRV monitoring not reliable)
  • inflicted trauma (different underlying pathophysiology)
  • patients or parents who do not speak or read English or French.

Treatment and study plan

HRV monitoring

Diagnostic Test

HRV monitoring derived from electrocardiogram

Primary outcomes

  1. % of the time with reliable HRVmonitoring in children with TBI

    Time frame: 1 year

    Feasibility of having a reliable capture and analysis of HRV 7 days post TBI

Secondary outcomes

  1. Rate of adverse events preceded by a decreased HRV

    Time frame: 1 year

    Adverse events will be defined as increased intracranial pressure, decreased CPP, seizure and cardiac arrest

  2. HRV and neurological outcome

    Time frame: 1.5 year

    The primary outcome of neurological and functional outcome will be assessed by the Pediatric Glasgow Outcome Scale Extended (P-GOSE) 6 months post TBI. P-GOSE is an 8-point ordinal scale (1= best outcome) The score will be classified as favourable (P-GOSE 1 or 2, or decreased of P-GOSE of 1 point post PICU (∆ P-GOSE ≤1) or unfavourable (P-GOSE ≥3 or ∆ P-GOSE ≥2)

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Registry information

Official study title

Heart Rate Variability in Children With Traumatic Brain Injury and Neurological Outcome

Acronym: HRV-TBI

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Oct 10, 2018
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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