Trial Summary
What is the purpose of this trial?This will be a five year study that will be a prospective, randomized, controlled trial (RCT) to assess the effect of a virtual early intervention care delivery model in the provision of therapy to enhance the neurodevelopmental trajectory of infants with brain injury. In addition, the investigators will enhance understanding of the social and parental contributors to outcomes and the early health economic impact of a virtual clinic. The results of this study will help inform the design of a larger, multi-center randomized controlled trial.
Eligibility Criteria
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.Inclusion Criteria
I have undergone therapeutic hypothermia treatment.
I have been diagnosed with severe brain damage due to lack of oxygen.
Exclusion Criteria
I am not fluent in English.
I have or am suspected to have a genetic syndrome.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Virtual CareExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention
Virtual Care is already approved in Canada for the following indications:
🇨🇦 Approved in Canada as Virtual Care for:
- Acute Kidney Injury (AKI)
- Reducing hospital readmission rates
- Improving long-term outcomes
Find a clinic near you
Research locations nearbySelect from list below to view details:
The Hospital for Sick ChildrenToronto, Canada
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Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor