Early Virtual Intervention for Infants With CP Following HIE Diagnosis

Cerebral Palsy Clinical Trial

— RECOVER  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04913324
• Other study ID #: 1000064940
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2021
• Source: The Hospital for Sick Children
• Contact: Sara Santini, BSc
• Phone: 416-813-7654
• Email: sara.santini[@]sickkids.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Months to 5 Months

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Injuries
• Brain Ischemia
• Cerebral Palsy
• Hypoxia
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy
• Perinatal Hypoxia

Intervention

Behavioral:
• Virtual 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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Sociodemographic factors that contribute to improved neurodevelopmental outcomes at 18 months as reported using a Sociodemographics Questionnaire		18 months
Secondary	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