Early Virtual Intervention for Infants With CP Following HIE Diagnosis

NCT04913324 | Not Yet Recruiting

• 1 other identifier: 1000064940
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

HIE; Cerebral Palsy; Infant; Virtual Care; Hypoxic-Ischemic Encephalopathy; Follow-Up; Brain Injuries; Perinatal Hypoxia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Virtual Care

EXPERIMENTAL

Behavioral: Virtual Care

Standard of Care

NO INTERVENTION

Interventions

Virtual Care BEHAVIORAL

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.

Virtual Care

Eligibility Criteria

• Age: 4 Months - 5 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of moderate to severe hypoxic ischemic encephalopathy as defined based on Sarnat criteria 35
• Received therapeutic hypothermia
• Abnormal brain MRI (deep grey matter, watershed or mixed patterns of injury) in the first seven days of life
• Greater than or equal to 34 weeks gestation
• Patients are followed by the Neonatal Follow-Up Clinic at SickKids
• Abnormal GMA (abnormal or absent fidgety movements) at 12 weeks of age

You may not qualify if:

• Known or high suspicion of a genetic syndrome
• Residence post-discharge will not be with biological parents
• Limited fluency in English
• No internet access

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (2)

• Al Kalaf H, Martinez A, Danguecan A, Christensen R, Tam EWY, Chau V, Wilson D, Tung S, Branson HM, Ly LG, Cizmeci MN. The Prognostic Weight of Clinical, Biochemical, Electrographic, and Neuroimaging Biomarkers in Perinatal Hypoxic-Ischemic Encephalopathy Spectrum. J Pediatr. 2025 Oct 31;289:114885. doi: 10.1016/j.jpeds.2025.114885. Online ahead of print.

  PMID: 41177395 DERIVED

• Raghu K, Kalish BT, Tam EWY, El Shahed A, Chau V, Wilson D, Tung S, Kazazian V, Miran AA, Hahn C, Branson HM, Ly LG, Cizmeci MN. Prognostic Indicators of Reorientation of Care in Perinatal Hypoxic-Ischemic Encephalopathy Spectrum. J Pediatr. 2025 Jan;276:114273. doi: 10.1016/j.jpeds.2024.114273. Epub 2024 Aug 30.

  PMID: 39216619 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Hypoxia-Ischemia, Brain; Brain Injuries

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Cerebrovascular Disorders; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Linh Ly, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Santini, BSc

CONTACT

416-813-7654; sara.santini@sickkids.ca

Rosanna Yankanah, MSc

CONTACT

416-816-7654; rosanna.yankanah@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 18 month follow-up assessment will be completed by a blinded clinician
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, NICU and Neonatal Neurodevelopmental Follow-up Clinic

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: June 4, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)