Early Virtual Intervention for Infants With CP Following HIE Diagnosis

N/ANot Yet RecruitingNCT04913324

The Hospital for Sick Children150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

150

Conditions

Cerebral Palsy Hypoxic-Ischemic Encephalopathy Brain Injuries Perinatal Hypoxia

Eligibility

Sex: ALLMin age: 4 MonthsMax age: 5 Months

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 18 months

Secondary Outcomes

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

Time frame: 18 months

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

Time frame: 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.

Time frame: 18 months

Early Virtual Intervention for Infants With CP Following HIE Diagnosis

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts