RIC in HIE: A Safety and Feasibility Trial

NACompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

January 17, 2022

Primary Completion Date

February 5, 2024

Study Completion Date

February 5, 2024

Conditions
Hypoxic-Ischemic Encephalopathy
Interventions
DEVICE

Remote Ischemic Conditioning

"Patients randomized to the RIC arm, cohorts of 4 consecutive patients will receive escalating therapy:~A. 4 consecutive patients will undergo 4 cycles of 3 minutes ischemia, followed by 5 minutes reperfusion, on Day 1 of therapeutic hypothermia B. Observing no safety events (see below) from patients in group A, 4 consecutive patients will undergo 4 cycles of 5 minutes ischemia, followed by 5 minutes reperfusion, on Day 1 of therapeutic hypothermia.~C. Observing no safety events from patients in group B, 4 consecutive patients will undergo 4 cycles of 5 minutes ischemia, followed by 5 minutes reperfusion, on Days 1 and 2 of therapeutic hypothermia.~D. Observing no safety events from patients in group C, 4 consecutive patients will undergo 4 cycles of 5 minutes ischemia, followed by 5 minutes reperfusion, on Days 1, 2, and 3 of therapeutic hypothermia.~All infants will have an extra 1ml of blood collected."

Trial Locations (1)

M5G 1X8

The Hospital for Sick Children, Toronto

All Listed Sponsors
lead

The Hospital for Sick Children

OTHER