Remote Ischemic Conditioning for Hypoxic-Ischemic Encephalopathy

The Hospital for Sick Children, Toronto, Canada
Hypoxic-Ischemic EncephalopathyRemote Ischemic Conditioning - Device
Eligibility
Any Age
All Sexes

Study Summary

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

Eligible Conditions
  • Hypoxic-Ischemic Encephalopathy

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Single patient room

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: 18-24 months

18-24 months
Neurodevelopmental follow-up outcomes at 18-24 months corrected age
Neurodevelopmental follow-up outcomes of hearing at 18-24 months corrected age
Neurodevelopmental follow-up outcomes of visual impairment at 18-24 months corrected age
Low Vision
Number of patients with cognitive, motor, and/or language impairment at 18-24 months corrected age defined as < 85 (impairment) and <70 (severe impairment) on the Bayley Scales of Infant and Toddler Development (3rd edition)
Number of patients with deafness or hearing impairment on decibel scale at 18-24 months corrected age
24 hours
Cutaneous Injury
Number of patients with cutaneous injury
Number of patients with transient and persistent pain defined as a premature infant pain profile (PIPP) score >7
Transient and persistent pain
4 hours
aEEG
7 days
MRI including diffusion-weighted imaging and spectroscopy
72 hours
Biomarkers
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
RIC Feasibility
RIC cycles administered as planned (Y/N)

Trial Safety

Phase-Based Safety

1 of 3

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1
Melatonin
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Control Arm - No Remote Ischemic Conditioning
1 of 2
Intervention Arm - Remote Ischemic Conditioning
1 of 2

Active Control

Experimental Treatment

32 Total Participants · 2 Treatment Groups

Primary Treatment: Remote Ischemic Conditioning · No Placebo Group · N/A

Intervention Arm - Remote Ischemic Conditioning
Device
Experimental Group · 1 Intervention: Remote Ischemic Conditioning · Intervention Types: Device
Control Arm - No Remote Ischemic ConditioningNoIntervention Group · 1 Intervention: Control Arm - No Remote Ischemic Conditioning · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Remote Ischemic Conditioning
2013
Completed Phase 3
~1790

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 18-24 months

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
649 Previous Clinical Trials
6,920,979 Total Patients Enrolled
Brian Kalish, MDPrincipal InvestigatorThe Hospital for Sick Children

Eligibility Criteria

Age Any Age · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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