Health TrialsbyHealthPanel

Early Virtual Intervention for Infants With CP Following HIE Diagnosis

ConditionsCerebral PalsyHypoxic-Ischemic EncephalopathyBrain InjuriesPerinatal Hypoxia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-5
SponsorThe Hospital for Sick Children

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Known or high suspicion of a genetic syndrome

Residence post-discharge will not be with biological parents

Limited fluency in English

No internet access

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Virtual CareExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Hospital for Sick Children

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: