Traumatic Brain InjuryHRV-TBINCT03701620
Heart Rate Variability in Children With Traumatic Brain Injury
An observational study of Traumatic Brain Injury and Child Development, run by St. Justine's Hospital at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Traumatic Brain Injury, Child Development
- What is being tested?
- HRV monitoring
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2018to 10 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children requiring PICU admission after TBI
Who may be able to join
- <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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heart Rate Variability in Children With Traumatic Brain Injury and Neurological Outcome
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.
Read the 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.
- Conditions
- Traumatic Brain Injury, Child Development
- Being tested
- HRV monitoring
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRV monitoringDiagnostic test
HRV monitoring derived from electrocardiogram
What is being measured
The primary outcome is the main question the study is designed to answer.
% of the time with reliable HRVmonitoring in children with TBI
Feasibility of having a reliable capture and analysis of HRV 7 days post TBI
Measured: 1 year
Secondary outcomes (2)
Rate of adverse events preceded by a decreased HRV
Adverse events will be defined as increased intracranial pressure, decreased CPP, seizure and cardiac arrest
Measured: 1 year
HRV and neurological outcome
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)
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start1 Jan 2018
- Primary completion5 Jul 2019
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurence Ducharme-Crevier, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701620
- Sponsor's protocol ID
- HSJ 2018-1575
- Acronym
- HRV-TBI
- Status last verified
- Oct 2021
- First submitted
- 3 Oct 2018
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability in Children With Traumatic Brain Injury and Neurological Outcome
- ClinicalTrials.gov ID
- NCT03701620
- Acronym / sponsor ID
- HRV-TBI / HSJ 2018-1575
- Conditions
- Traumatic Brain Injury, Child Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 5 Jul 2019 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 10 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children requiring PICU admission after TBI
Key inclusion criteria (4 listed)
- <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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRV monitoringHRV monitoring derived from electrocardiogram | Diagnostic test | – |
Primary outcome
% 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
2 secondary outcomes
Rate of adverse events preceded by a decreased HRV
Time frame: 1 year
HRV and neurological outcome
Time frame: 1.5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Child Development, run by St. Justine's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of the time with reliable HRVmonitoring in children with TBI (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.