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Remote Ischemic Conditioning for Hypoxic-Ischemic Encephalopathy

N/A

Waitlist Available

Led By Brian Kalish, MD

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18-24 months

Awards & highlights

Study Summary

This trial has never been done on humans, but it has been studied in animals with encouraging results.

Who is the study for?

This trial is for newborns with a condition called Hypoxic-Ischemic Encephalopathy (HIE) who qualify for therapeutic hypothermia. They must be at least 35 weeks gestational age, without brain malformations, genetic anomalies, metabolic errors, and not needing high levels of oxygen or significant blood pressure support before the treatment.Check my eligibility

What is being tested?

The trial is testing Remote Ischemic Conditioning (RIC) on newborns with HIE to see if it's safe and can help. RIC involves briefly restricting blood flow to limbs to potentially protect the brain from damage due to low oxygen.See study design

What are the potential side effects?

Since this is a first-time study in newborns with HIE, specific side effects are unknown but may include discomfort or bruising where blood flow is restricted during RIC.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18-24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18-24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18-24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

RIC cycles administered as planned (Y/N)

Secondary outcome measures

Number of patients with cutaneous injury

Number of patients with transient and persistent pain defined as a premature infant pain profile (PIPP) score >7

Other outcome measures

Biomarkers

MRI including diffusion-weighted imaging and spectroscopy

Low Vision

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention Arm - Remote Ischemic ConditioningExperimental Treatment1 Intervention

Remote Ischemic Conditioning

Group II: Control Arm - No Remote Ischemic ConditioningActive Control1 Intervention

No intervention. A blood pressure cuff will be placed on the infant's arm but will not be inflated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Remote Ischemic Conditioning

2022

Completed Phase 3

~1820

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor

686 Previous Clinical Trials

6,944,761 Total Patients Enrolled

Brian Kalish, MDPrincipal InvestigatorThe Hospital for Sick Children

Media Library

Remote Ischemic Conditioning (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05379218 — N/A

Hypoxic-Ischemic Encephalopathy Research Study Groups: Intervention Arm - Remote Ischemic Conditioning, Control Arm - No Remote Ischemic Conditioning

Hypoxic-Ischemic Encephalopathy Clinical Trial 2023: Remote Ischemic Conditioning Highlights & Side Effects. Trial Name: NCT05379218 — N/A

Remote Ischemic Conditioning (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05379218 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are taking part in this trial?

"Affirmative. Per the information released on clinicaltrials.gov, this research trial is in current need of subjects. The study was initially posted on January 17th 2022 and was most recently modified on October 18th 2022. 32 volunteers are being recruited from 1 location for participation in the experiment."

Answered by AI

What is the desired outcome of this research project?

"During this 72 hour clinical trial, the primary assessment will be centered around gauging the feasibility of this study. Secondary objectives include observing any transient and persistent pain via PIPP score > 7 as well as monitoring for cutaneous injury within 24 hours after completion of the maneuver compared to baseline assessments. Lastly, a patient's status regarding transient/persistent pain shall also be determined based on their respective PIPP scores over 6 hour intervals post-maneuver."

Answered by AI

What is the current status of this research endeavor with regard to patient enrollment?

"Affirmative. Clinicaltrials.gov reports that the recruitment process for this trial, which was first posted on January 17th 2022, is ongoing with 32 participants being accepted at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

RIC in HIE: A Safety and Feasibility Trial

Brian Kalish 2022. "RIC in HIE: A Safety and Feasibility Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05379218.