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Virtual Intervention for Infants with Cerebral Palsy (RECOVER Trial)

N/A

Waitlist Available

Led By Linh Ly, MD

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Received therapeutic hypothermia

Diagnosis of moderate to severe hypoxic ischemic encephalopathy as defined based on Sarnat criteria 35

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

RECOVER Trial Summary

This trial will test if a virtual early intervention care delivery model can help infants with brain injury in their neurodevelopment.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Since the intervention involves non-invasive virtual care rather than medication or surgery, traditional side effects are not expected. However, there may be indirect impacts on family dynamics or stress levels due to the nature of remote interactions.

RECOVER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have undergone therapeutic hypothermia treatment.

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I have been diagnosed with severe brain damage due to lack of oxygen.

RECOVER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Motor outcomes at 18 months between groups using the the motor function score as measured using the Bayley Scales of Infant and Toddler Development

Secondary outcome measures

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

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.

Sociodemographic factors that contribute to improved neurodevelopmental outcomes at 18 months as reported using a Sociodemographics Questionnaire

RECOVER Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Virtual CareExperimental Treatment1 Intervention

Group II: Standard of CareActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Virtual Care

2021

N/A

~100

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor

687 Previous Clinical Trials

6,944,883 Total Patients Enrolled

11 Trials studying Cerebral Palsy

4,555 Patients Enrolled for Cerebral Palsy

Linh Ly, MDPrincipal InvestigatorThe Hospital for Sick Children

Media Library

Virtual Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT04913324 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to join this investigation?

"For this research venture, 150 infants aged between 4 and 5 months with brain injuries must be enrolled. To be eligible for the study, these young patients need to have surpassed 34 weeks of gestation as well as being clients at SickKids' Neonatal Follow-Up Clinic."

Answered by AI

Is it still possible to become part of this research initiative?

"The trial, initially posted on June 1st 2021 and last updated May 28th of the same year, is not currently enrolling patients. However, out of the 735 other clinical trials actively seeking volunteers at this time, one may be suitable for you."

Answered by AI

Are applicants over the age of 79 being considered for this research?

"According to the outlined eligibility criteria, patients must be between 4 and 5 months of age. Additionally, there are 270 clinical trials available for minors and 436 specifically designed for seniors."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Early Virtual Intervention for Infants With CP Following HIE Diagnosis

Linh Ly 2021. "Early Virtual Intervention for Infants With CP Following HIE Diagnosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04913324.

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