Early Virtual Intervention for Infants With CP Following HIE Diagnosis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-5
SponsorThe Hospital for Sick Children

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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 design

Treatments tested in this trial

  • Virtual Care

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators