Heart Rate Variability in Children With Traumatic Brain I... | NCT03701620

Studies
Heart Rate Variability in Children With Traumatic Brain Injury

NCT03701620

Sponsor

St. Justine's Hospital

Status

Completed

Last Update Posted

Oct 6, 2021Actual

Enrollment

15Actual

Phase

Not provided

Conditions

Traumatic Brain Injury
Child Development

Interventions

HRV monitoring

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Jul 5, 2019Actual

Completion Date

Feb 10, 2021Actual

First Submitted Date

Oct 3, 2018

First Submission Date that Met QC Criteria

Oct 8, 2018

First Posted Date

Oct 10, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2021

Last Update Posted Date

Oct 6, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Laurence Ducharme-Crevier, Pediatric intensivist, Principal Investigator, St. Justine's HospitalPrincipal Investigator

Lead Sponsor

St. Justine's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HRV monitoring	Diagnostic Test	HRV monitoring derived from electrocardiogram

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
% of the time with reliable HRVmonitoring in children with TBI	Feasibility of having a reliable capture and analysis of HRV 7 days post TBI	1 year

Secondary Outcomes

Measure	Description	Time Frame
Rate of adverse events preceded by a decreased HRV	Adverse events will be defined as increased intracranial pressure, decreased CPP, seizure and cardiac arrest	1 year
HRV and neurological outcome

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children requiring PICU admission after TBI

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Sainte-Justine		Montreal	Quebec	H3T 1C5	Canada

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

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)