Brain Injuries, Cerebral Palsy, Hypoxic-Ischemic Encephalopathy, Perinatal Hypoxia
Conditions
Keywords
HIE, Cerebral Palsy, Infant, Virtual Care, Hypoxic-Ischemic Encephalopathy, Follow-Up, Brain Injuries, Perinatal Hypoxia
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 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.
Interventions
BEHAVIORALVirtual 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.
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
18 month follow-up assessment will be completed by a blinded clinician
Eligibility
Sex/Gender
ALL
Age
4 Months to 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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Canada
Contacts
Primary ContactSara Santini, BSc
Backup ContactRosanna Yankanah, MSc
Outcome results
None listed