Status:
COMPLETED
RIC in HIE: A Safety and Feasibility Trial
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Hypoxic-Ischemic Encephalopathy
Eligibility:
All Genders
Phase:
NA
Brief Summary
Remote Ischemic Conditioning has never been studied in neonates with HIE. However, RIC has been studied in animal models of perinatal asphyxia and has shown encouraging results. In neonatal rats with ...
Detailed Description
Hypoxic-ischemic encephalopathy (HIE) is a devastating condition in which newborn infants are deprived of oxygen in the peripartum period, resulting in brain injury. HIE is a leading cause of infant m...
Eligibility Criteria
Inclusion
- Qualifying for therapeutic hypothermia according to the primary care team based on the current SickKids HIE Protocol
Exclusion
- Gestational age \<35 weeks
- Known central nervous system malformations
- Known chromosomal or genetic anomalies
- Confirmed or suspected inborn error of metabolism
- Parental decision for withdrawal of life-sustaining treatment ("comfort care"). If this decision is made after enrollment but before completion of RIC intervention, no further study-related intervention will be performed.
- Patients requiring significant hemodynamic support (two or more agents for blood pressure support, \>0.05mcg/kg/min epinephrine infusion, or \>0.1 mU/kg/min vasopressin) for the four hour period prior to RIC
- Patients requiring inhaled nitric oxide or fraction of inspired oxygen (FiO2) \>50% for the four-hour period prior to RIC
Key Trial Info
Start Date :
January 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05379218
Start Date
January 17 2022
End Date
February 5 2024
Last Update
March 7 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8