Cerebral PalsyRECOVERNCT04913324
Early Virtual Intervention for Infants With CP Following HIE Diagnosis
A study testing Virtual Care in people with Cerebral Palsy and Hypoxic-Ischemic Encephalopathy, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 5 months
- Conditions the study is for
- Cerebral Palsy, Hypoxic-Ischemic Encephalopathy, Brain Injuries
- What is being tested?
- Virtual Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 5 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Known or high suspicion of a genetic syndrome
- Residence post-discharge will not be with biological parents
- Limited fluency in English
- No internet access
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Sara Santini, BSc, 416-813-7654 ext. 202827, sara.santini@sickkids.ca
Rosanna Yankanah, MSc, 416-813-7654 ext. 202919, rosanna.yankanah@sickkids.ca
About this study
Official title: The RECOVER Study - Remote Early Intervention for Cerebral Palsy to Improve Outcomes Using Virtual Care Following pERinatal Asphyxia
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.
- Being tested
- Virtual Care
- Keywords
- HIE, Cerebral Palsy, Infant, Virtual Care, Hypoxic-Ischemic Encephalopathy, Follow-Up, Brain Injuries, Perinatal Hypoxia
- Medical subject headings
- Cerebral Palsy, Hypoxia-Ischemia, Brain, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual CareBehavioural
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 group | Role | What they receive |
|---|---|---|
| Virtual Care | Experimental | Not described Receives: Behavioral: Virtual Care |
| Standard of Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor outcomes at 18 months between groups using the the motor function score as measured using the Bayley Scales of Infant and Toddler Development
Measured: 18 months
Secondary outcomes (3)
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
Measured: 18 months
Sociodemographic factors that contribute to improved neurodevelopmental outcomes at 18 months as reported using a Sociodemographics Questionnaire
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start1 Jun 2021 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linh Ly, The Hospital for Sick Children
- Investigators
- Linh Ly, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913324
- Sponsor's protocol ID
- 1000064940
- Acronym
- RECOVER
- Status last verified
- May 2021
- First submitted
- 7 Apr 2021
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41177395Raghu 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.
PubMed 39216619
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RECOVER Study - Remote Early Intervention for Cerebral Palsy to Improve Outcomes Using Virtual Care Following pERinatal Asphyxia
- ClinicalTrials.gov ID
- NCT04913324
- Acronym / sponsor ID
- RECOVER / 1000064940
- Keywords
- HIE, Cerebral Palsy, Infant, Virtual Care, Hypoxic-Ischemic Encephalopathy, Follow-Up, Brain Injuries, Perinatal Hypoxia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Care | Experimental | Behavioral: Virtual Care |
| Standard of Care | No intervention | – |
Who may qualify
- Ages
- 4 to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Known or high suspicion of a genetic syndrome
- Residence post-discharge will not be with biological parents
- Limited fluency in English
- No internet access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual CareInfants 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. | Behavioural | Virtual Care |
Primary outcome
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
3 secondary outcomes
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
Sociodemographic factors that contribute to improved neurodevelopmental outcomes at 18 months as reported using a Sociodemographics Questionnaire
Time frame: 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.
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Derived from this study: PubMed 41177395Al 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.
- Derived from this study: PubMed 39216619Raghu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Linh Ly, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Care in people with Cerebral Palsy and Hypoxic-Ischemic Encephalopathy, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Santini, BSc (416-813-7654 ext. 202827, sara.santini@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04913324, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021.