The RECOVER Study - Remote Early Intervention for Cerebral Palsy to Improve Outcomes Using Virtual Care Following pERinatal Asphyxia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Motor outcomes at 18 months between groups using the the motor function score as measured using the Bayley Scales of Infant and Toddler Development
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
18 month follow-up assessment will be completed by a blinded clinician
入排标准
- 年龄范围
- 4 Months 至 5 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Known or high suspicion of a genetic syndrome
- •Residence post-discharge will not be with biological parents
- •Limited fluency in English
- •No internet access
研究组 & 干预措施
Standard of Care
Virtual Care
干预措施: Virtual Care (Behavioral)
结局指标
主要结局
Motor outcomes at 18 months between groups using the the motor function score as measured using the Bayley Scales of Infant and Toddler Development
时间窗: 18 months
次要结局
- 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)
研究者
Linh Ly
Medical Director, NICU and Neonatal Neurodevelopmental Follow-up Clinic
The Hospital for Sick Children