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Heart Rate Variability in Children With Traumatic Brain Injury

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03701620
Acronym
HRV-TBI
Enrollment
15
Registered
2018-10-10
Start date
2018-01-01
Completion date
2021-02-10
Last updated
2021-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Development, Traumatic Brain Injury

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTHRV monitoring

HRV monitoring derived from electrocardiogram

Sponsors

St. Justine's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
% of the time with reliable HRVmonitoring in children with TBI1 yearFeasibility of having a reliable capture and analysis of HRV 7 days post TBI

Secondary

MeasureTime frameDescription
Rate of adverse events preceded by a decreased HRV1 yearAdverse events will be defined as increased intracranial pressure, decreased CPP, seizure and cardiac arrest
HRV and neurological outcome1.5 yearThe 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)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026