Early Virtual Intervention for Infants With CP Following HIE Diagnosis (RECOVER)

The Hospital for Sick Children

Status: Not yet enrolling

Conditions: Brain Injuries; Cerebral Palsy; Perinatal Hypoxia; Hypoxic-Ischemic Encephalopathy

Treatments: Behavioral: Virtual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04913324

1000064940

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 4 to 5 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Virtual Care

Experimental group

Treatment:

Behavioral: Virtual Care

Standard of Care

No Intervention group