Virtual Intervention for Infants with Cerebral Palsy
(RECOVER Trial)

Recruiting in Palo Alto (17 mi)

Overseen byLinh Ly, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: The Hospital for Sick Children

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of 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

This trial is for infants with brain injuries related to oxygen deprivation at birth, specifically those who have had abnormal movements by 12 weeks old, were born after 34 weeks of pregnancy, received cooling therapy, are followed by the Neonatal Follow-Up Clinic at SickKids, and have an abnormal brain MRI. Infants must also be diagnosed with moderate to severe hypoxic ischemic encephalopathy. Those with genetic syndromes, not living with biological parents post-discharge, limited English fluency or no internet can't participate.

Inclusion Criteria

I have undergone therapeutic hypothermia treatment.

Your baby does not show normal movements by 12 weeks old.

You are at least 34 weeks pregnant.

See 3 more

Exclusion Criteria

I am not fluent in English.

I have or am suspected to have a genetic syndrome.

No internet access

See 1 more

Treatment Details

Interventions

Virtual Care (Behavioral Intervention)

Trial OverviewThe study tests a virtual care model over five years to see if it improves development in infants with brain injury from lack of oxygen at birth. It's a randomized controlled trial comparing usual care against this new virtual intervention method while examining parental impact and cost-effectiveness.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Virtual CareExperimental Treatment1 Intervention

Group II: Standard of CareActive Control1 Intervention

Virtual Care is already approved in Canada for the following indications:

🇨🇦 Approved in Canada as Virtual Care for: