Multicenter Randomized Controlled Trial (RCT) and Efficacy Evaluation System Study on Surgical Innovation Strategies for Neonatal Complex Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 738
- 试验地点
- 12
- 主要终点
- Perioperative Mortality and Non-Rehabilitation Discharge Rate
研究概览
简要总结
There remains controversy regarding the optimal timing of surgical treatment for neonatal CCHD (Complex Congenital Heart Disease). Based on the established national multi-center database for surgical treatment of congenital heart disease and the prenatal-postnatal integrated diagnosis and treatment model, this study will conduct a multi-center RCT (Randomized Controlled Trial) to explore the optimal surgical timing for neonatal CCHD. It will also develop innovative comprehensive treatment strategies for critically ill neonatal CCHD patients, use RCT data to evaluate treatment efficacy and establish an evaluation system. This system will be gradually promoted nationwide, aiming to reduce the incidence of perioperative mortality and non-recovery discharge in CCHD patients by 50% (National in-hospital mortality rate of neonatal congenital heart disease surgery in 2023: 6.5%; non-recovery discharge rate: 12.66%), thereby improving the overall level of CCHD treatment in China.
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
- None
入排标准
- 年龄范围
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates diagnosed with TAPVC, CoA/IAA, TGA, PA/IVS, or severe PS via pre-admission cardiac echocardiography;
- •Patients and families demonstrating high compliance, willing to sign informed consent forms and agree to complete one year of follow-up and related examinations.
排除标准
- •Preterm infant (gestational age < 36 weeks at birth);
- •Low birth weight (weight < 2.5 kg);
- •Concurrent severe extracardiac anomalies or complex cardiac malformations;
- •Preoperative respiratory or circulatory instability requiring emergency surgery.
研究组 & 干预措施
Control Group
Surgical operation is performed on neonates aged >7 days (postnatal age)
干预措施: Surgical operation is performed on neonates aged >7 days (postnatal age) (Procedure)
Experimental Group
Surgical operation is performed on neonates aged < 7 days (postnatal age)
干预措施: Surgical operation is performed on neonates aged < 7 days (postnatal age). (Procedure)
结局指标
主要结局
Perioperative Mortality and Non-Rehabilitation Discharge Rate
时间窗: From enrollment to 1 year after surgery
次要结局
未报告次要终点
研究者
Qihang Yang
postgraduate student
Central China Fuwai Hospital of Zhengzhou University