Early Virtual Intervention for Infants With CP Following HIE Diagnosis

Study Overview
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Brief Summary
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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.

Official Title
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The RECOVER Study - Remote Early Intervention for Cerebral Palsy to Improve Outcomes Using Virtual Care Following pERinatal Asphyxia

Conditions
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Hypoxic-Ischemic Encephalopathy, Cerebral Palsy, Brain Injuries, Perinatal Hypoxia

Intervention / Treatment
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* Behavioral: Virtual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: Known or high suspicion of a genetic syndrome Residence post-discharge will not be with biological parents Limited fluency in English No internet access

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 5 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Care<br> | Behavioral: Virtual Care<br>* 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.<br>|
| No Intervention: Standard of Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Palsy, Infant, Virtual Care, Hypoxic-Ischemic Encephalopathy, Follow-Up, Brain Injuries, Perinatal Hypoxia, HIE