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Early Virtual Intervention for Infants With CP Following HIE Diagnosis

NCT04913324 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-06-04

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy
  • Hypoxic-Ischemic Encephalopathy
  • Brain Injuries
  • Perinatal Hypoxia

Interventions

BEHAVIORAL

Virtual Care

Infants randomized at 4 months of age to the intervention arm will participate in virtual care visits for 16 weeks in addition to standard of care in-hospital visits.

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Linh Ly, MD · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
5 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2024-12-31
Completion
2026-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04913324 on ClinicalTrials.gov