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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Care | Experimental |
| |
| Standard of Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Care | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between parent mental health using the modified Perinatal PTSD Questionnaire, Parent Stress Index, and neurodevelopmental outcomes of patients at 18 months using the Bayley Scales of Infant and Toddler Development | 18 months | |
| Sociodemographic factors that contribute to improved neurodevelopmental outcomes at 18 months as reported using a Sociodemographics Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Santini, BSc | Contact | 416-813-7654 | 202827 | sara.santini@sickkids.ca |
| Rosanna Yankanah, MSc | Contact | 416-816-7654 | 202919 | rosanna.yankanah@sickkids.ca |
| Name | Affiliation | Role |
|---|---|---|
| Linh Ly, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41177395 | Derived | Al Kalaf H, Martinez A, Danguecan A, Christensen R, Tam EWY, Chau V, Wilson D, Tung S, Branson HM, Ly LG, Cizmeci MN. The Prognostic Weight of Clinical, Biochemical, Electrographic, and Neuroimaging Biomarkers in Perinatal Hypoxic-Ischemic Encephalopathy Spectrum. J Pediatr. 2026 Feb;289:114885. doi: 10.1016/j.jpeds.2025.114885. Epub 2025 Oct 31. | |
| 39216619 |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D020925 | Hypoxia-Ischemia, Brain |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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18 month follow-up assessment will be completed by a blinded clinician
| 18 months |
| Cost-effectiveness of providing remote, early, intensive therapy for children at risk for cerebral palsy versus standard of care as reported using a Health Economics Questionnaire. | 18 months |
| Raghu K, Kalish BT, Tam EWY, El Shahed A, Chau V, Wilson D, Tung S, Kazazian V, Miran AA, Hahn C, Branson HM, Ly LG, Cizmeci MN. Prognostic Indicators of Reorientation of Care in Perinatal Hypoxic-Ischemic Encephalopathy Spectrum. J Pediatr. 2025 Jan;276:114273. doi: 10.1016/j.jpeds.2024.114273. Epub 2024 Aug 30. |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |