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NCT Number: NCT04913324

Early Virtual Intervention for Infants With CP Following HIE Diagnosis

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Brain Injuries Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Hypoxic-Ischemic Encephalopathy Nervous System Diseases Pathological Conditions, Signs and Symptoms Perinatal Hypoxia Signs and Symptoms Signs and Symptoms, Respiratory Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

4 month–5 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

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

    Time frame: 18 months

Secondary outcomes

  1. 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

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

    Time frame: 18 months

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Rosanna Yankanah, MSc

CONTACT

[email protected]

416-816-7654 ext. 202919

Sara Santini, BSc

CONTACT

[email protected]

416-813-7654 ext. 202827

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

The RECOVER Study - Remote Early Intervention for Cerebral Palsy to Improve Outcomes Using Virtual Care Following pERinatal Asphyxia

Acronym: RECOVER

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Jun 4, 2021
Registry last updated
Jun 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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