Early Virtual Intervention for Infants With CP Following HIE Diagnosis (RECOVER)
Primary Purpose
Cerebral Palsy, Hypoxic-Ischemic Encephalopathy, Brain Injuries
Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Virtual Care
Sponsored by
About this trial
This is an interventional supportive care trial for Cerebral Palsy focused on measuring HIE, Cerebral Palsy, Infant, Virtual Care, Hypoxic-Ischemic Encephalopathy, Follow-Up, Brain Injuries, Perinatal Hypoxia
Eligibility Criteria
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
Sites / Locations
- The Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Virtual Care
Standard of Care
Arm Description
Outcomes
Primary Outcome Measures
Motor outcomes at 18 months between groups using the the motor function score as measured using the Bayley Scales of Infant and Toddler Development
Secondary Outcome Measures
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
Sociodemographic factors that contribute to improved neurodevelopmental outcomes at 18 months as reported using a Sociodemographics Questionnaire
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.
Full Information
NCT ID
NCT04913324
First Posted
April 7, 2021
Last Updated
May 28, 2021
Sponsor
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT04913324
Brief Title
Early Virtual Intervention for Infants With CP Following HIE Diagnosis
Acronym
RECOVER
Official Title
The RECOVER Study - Remote Early Intervention for Cerebral Palsy to Improve Outcomes Using Virtual Care Following pERinatal Asphyxia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Hypoxic-Ischemic Encephalopathy, Brain Injuries, Perinatal Hypoxia
Keywords
HIE, Cerebral Palsy, Infant, Virtual Care, Hypoxic-Ischemic Encephalopathy, Follow-Up, Brain Injuries, Perinatal Hypoxia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
18 month follow-up assessment will be completed by a blinded clinician
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual Care
Arm Type
Experimental
Arm Title
Standard of Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Virtual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Motor outcomes at 18 months between groups using the the motor function score as measured using the Bayley Scales of Infant and Toddler Development
Time Frame
18 months
Secondary Outcome Measure Information:
Title
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
Time Frame
18 months
Title
Sociodemographic factors that contribute to improved neurodevelopmental outcomes at 18 months as reported using a Sociodemographics Questionnaire
Time Frame
18 months
Title
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.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
5 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Santini, BSc
Phone
416-813-7654
Ext
202827
Email
sara.santini@sickkids.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Rosanna Yankanah, MSc
Phone
416-816-7654
Ext
202919
Email
rosanna.yankanah@sickkids.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linh Ly, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Santini, BSc
Phone
416-813-7654
Ext
202827
Email
sara.santini@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Rosanna Yankanah, MSc
Phone
416-813-7654
Ext
202919
Email
rosanna.yankanah@sickkids.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Early Virtual Intervention for Infants With CP Following HIE Diagnosis
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