Status:
NOT_YET_RECRUITING
Early Virtual Intervention for Infants With CP Following HIE Diagnosis
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Cerebral Palsy
Hypoxic-Ischemic Encephalopathy
Eligibility:
All Genders
4-5 years
Phase:
NA
Brief Summary
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 en...
Eligibility Criteria
Inclusion
- Diagnosis of moderate to severe hypoxic ischemic encephalopathy as defined based on Sarnat criteria 35
- Received therapeutic hypothermia
- Abnormal brain MRI (deep grey matter, watershed or mixed patterns of injury) in the first seven days of life
- Greater than or equal to 34 weeks gestation
- Patients are followed by the Neonatal Follow-Up Clinic at SickKids
- Abnormal GMA (abnormal or absent fidgety movements) at 12 weeks of age
Exclusion
- Known or high suspicion of a genetic syndrome
- Residence post-discharge will not be with biological parents
- Limited fluency in English
- No internet access
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04913324
Start Date
June 1 2021
End Date
December 31 2026
Last Update
June 4 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8