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Virtual Intervention for Infants with Cerebral Palsy (RECOVER Trial)

N/A
Waitlist Available
Led By Linh Ly, 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
Received therapeutic hypothermia
Diagnosis of moderate to severe hypoxic ischemic encephalopathy as defined based on Sarnat criteria 35
Must not have
Limited fluency in English
Known or high suspicion of a genetic syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a virtual early intervention care delivery model can help infants with brain injury in their neurodevelopment.

Who is the study for?
This trial is for infants with brain injuries related to oxygen deprivation at birth, specifically those who have had abnormal movements by 12 weeks old, were born after 34 weeks of pregnancy, received cooling therapy, are followed by the Neonatal Follow-Up Clinic at SickKids, and have an abnormal brain MRI. Infants must also be diagnosed with moderate to severe hypoxic ischemic encephalopathy. Those with genetic syndromes, not living with biological parents post-discharge, limited English fluency or no internet can't participate.
What is being tested?
The study tests a virtual care model over five years to see if it improves development in infants with brain injury from lack of oxygen at birth. It's a randomized controlled trial comparing usual care against this new virtual intervention method while examining parental impact and cost-effectiveness.
What are the potential side effects?
Since the intervention involves non-invasive virtual care rather than medication or surgery, traditional side effects are not expected. However, there may be indirect impacts on family dynamics or stress levels due to the nature of remote interactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have undergone therapeutic hypothermia treatment.
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I have been diagnosed with severe brain damage due to lack of oxygen.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not fluent in English.
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I have or am suspected to have a genetic syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Virtual CareExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Virtual Care
2021
N/A
~100

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
711 Previous Clinical Trials
6,958,130 Total Patients Enrolled
12 Trials studying Cerebral Palsy
6,548 Patients Enrolled for Cerebral Palsy
Linh Ly, MDPrincipal InvestigatorThe Hospital for Sick Children

Media Library

Virtual Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT04913324 — N/A
~0 spots leftby Dec 2024
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