NCT04913324

Early Virtual Intervention for Infants With CP Following HIE Diagnosis

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 4 Months – 5 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Palsy
• Hypoxic-Ischemic Encephalopathy
• Brain Injuries
• Perinatal Hypoxia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-12-31
• Completion: 2026-12-31
• First posted: 2021-06-04
• Last updated: 2021-06-04

Locations

1 site across 1 country: Canada