Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT03701620
Status:
COMPLETED
Last Update Posted:
2021-10-06
First Post:
2018-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Heart Rate Variability in Children With Traumatic Brain Injury
Sponsor:
St. Justine's Hospital
Organization:
Study Overview
Official Title:
Heart Rate Variability in Children With Traumatic Brain Injury and Neurological Outcome
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HRV-TBI
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: