Virtual Care: Infants randomized at 4 months of age to the intervention arm will participate in virtual care visits for 16 weeks in addition to standard of care in-hospital visits.
Study 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 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
Sex
ALL
Min age
4 Months
Max age
5 Months
Healthy volunteers
No
Inclusion Criteria:
1. Diagnosis of moderate to severe hypoxic ischemic encephalopathy as defined based on Sarnat criteria 35
2. Received therapeutic hypothermia
3. Abnormal brain MRI (deep grey matter, watershed or mixed patterns of injury) in the first seven days of life
4. Greater than or equal to 34 weeks gestation
5. Patients are followed by the Neonatal Follow-Up Clinic at SickKids
6. Abnormal GMA (abnormal or absent fidgety movements) at 12 weeks of age
Exclusion Criteria:
1. Known or high suspicion of a genetic syndrome
2. Residence post-discharge will not be with biological parents
3. Limited fluency in English
4. No internet access
Primary outcome measure(s)
Motor outcomes at 18 months between groups using the the motor function score as measured using the Bayley Scales of Infant and Toddler Development — 18 months
Trial sites (1)
Facility
City
Region
Status
The Hospital for Sick Children
Toronto
Ontario
More The Hospital for Sick Children trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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