2024-513041-37-00招募中3 期
CeRebrUm and CardIac protection with ALlopurinol in Neonates with Critical Congenital Heart Disease requiring Cardiac Surgery with Cardiopulmonary Bypass
Universitair Medisch Centrum Utrecht4 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2024年7月31日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 236
- 试验地点
- 4
- 主要终点
- Primary outcome is a composite endpoint of relevant (moderate / severe) parenchymatous brain injury on postoperative MRI or too instable for postoperative MRI or mortality.
研究概览
简要总结
To evaluate whether in newborns with critical congenital heart disease, early postnatal (after birth) and perioperative (around cardiac surgery with cardiopulmonary bypass) allopurinol compared to placebo (mannitol) administration reduces relevant (moderate / severe) parenchymatous brain injury on postoperative MRI.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Neonates with a prenatally (before birth) or postnatally (after birth) confirmed diagnosis of critical congenital heart disease requiring neonatal cardiac surgery with cardiopulmonary bypass within the first 4 weeks of life
排除标准
- •Inability to enroll the patient before the start of delivery, in case of prenatal diagnosis or 24h before surgery in case op postnatal diagnosis.
- •Doubt whether the aortic arch anomaly before birth requires cardiac surgery with CPB in the neonatal period.
- •Gestational age below 36 weeks and /or birth weight less than 2000 gram.
- •Patient considered "moribund".
- •Decision for "comfort care only"
- •Surgery not requiring cardiopulmonary bypass.
结局指标
主要结局
Primary outcome is a composite endpoint of relevant (moderate / severe) parenchymatous brain injury on postoperative MRI or too instable for postoperative MRI or mortality.
Primary outcome is a composite endpoint of relevant (moderate / severe) parenchymatous brain injury on postoperative MRI or too instable for postoperative MRI or mortality.
次要结局
- Brain injury severity score and volume of hypoxic-ischemic brain injury (pre- and postoperative MRI)
- Brain function: background pattern and seizure activity (postnatal and perioperative amplitude integrated electroencephalogram).
- Cerebral oxygenation (postnatal and perioperative near-infrared spectroscopy).
- Cardiac function (pre- and postoperative echocardiography).
- Neurodevelopmental outcome (general movements at 3 months and Bayley scales of infant development and executive functioning testing at 24 months).
- Quality of life (TNO-TAPQOL at 24 months)
- Cost effectiveness of allopurinol (questionnaires during hospital stay at 3 and 24 months)
- Pharmacokinetics of allopurinol (substudy: postnatally, perioperatively)
研究者
MJNL Benders
Scientific
Universitair Medisch Centrum Utrecht
研究点 (4)
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