Early Virtual Intervention for Infants With CP Following HIE Diagnosis

Not Applicable

Not yet recruiting

• Conditions: Cerebral Palsy; Hypoxic-Ischemic Encephalopathy; Brain Injuries; Perinatal Hypoxia
• Interventions: Behavioral: Virtual Care

• Registration Number: NCT04913324
• Lead Sponsor: The Hospital for Sick Children

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-07
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-28
• Last Update Submitted: 2021-05-28
• Study Start: 2021-06-01
• Study First Posted: 2021-06-04
• Last Update Posted: 2021-06-04
• Primary Completion: 2024-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Care	Virtual Care	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada