The Influence of Postoperative Systemic Oxygen Transport on Neurologic and Functional Outcomes in Infants Undergoing Single Ventricle Palliation With Norwood and Hybrid Management Strategies
试验速览
- 阶段
- 3 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Neurologic and functional outcomes
研究概览
简要总结
The purpose of this trial is to determine, at 3 years of life, how the neurologic and functional outcomes in infants with single ventricles are different when comparing children treated with the Hybrid strategy to the Norwood strategy.
详细描述
Neurologic deficits in children with single ventricle physiology are believed to be associated with the reconstruction of the aortic arch during the initial Norwood procedure as a neonate. In the last few years, a new management strategy (the 'Hybrid' strategy) has been proposed which defers the aortic arch reconstruction to a second stage procedure at 4-6 months of age.
Proponents of the Hybrid strategy assert that the avoidance of cardiopulmonary bypass and circulatory arrest in the neonatal period will avoid neurologic injury in the critical neonatal period and thereby result in superior long-term neurologic outcomes.
We are testing whether the Hybrid management strategy is associated with superior neurologic outcomes or not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of functional single ventricle anatomy amenable to Norwood or Hybrid first stage palliation.
- •Informed consent of parent(s) or legal guardian.
排除标准
- •Pre-operative identification of anatomy rendering either a Norwood or Hybrid procedure clinically inappropriate;
- •Recent history of significant cerebral bleed or necrotizing enterocolitis;
- •Severe hemodynamic instability;
- •Any other major congenital abnormality (i.e. congenital diaphragmatic hernia, tracheoesophageal fistula) or clinically significant acquired extra-cardiac disorder (e.g. meconium aspiration with need for high frequency ventilation, persistent renal failure requiring dialysis).
结局指标
主要结局
Neurologic and functional outcomes
时间窗: 3 years of age (during procedure 3 pre-op)
At \~3 years of age, the Vineland Scale,the Mullen Developmental Scale, and the BASC behavioural scale will be formally assessed
次要结局
- Hemodynamic Assessment(Baseline and 4-6 months)
- Blood Sampling(Baseline and 4-6 months)
- Systemic Oxygen Consumption(Baseline and 4-6 months)
- Cerebral Oxygen Transport Surrogate Measurements(Baseline and 4-6 months)
- Cerebral Blood Flow Velocity(Baseline and 4-6 months)
- Electroencephalograph(Baseline and 4-6 months)
- MRI scans(Baseline, 4-6 months and 2-3 years)