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Multicenter Randomized Controlled Trial (RCT) and Efficacy Evaluation System Study on Surgical Innovation Strategies for Neonatal Complex Congenital Heart Disease

RecruitingNAAges any - 7 DaysAllCentral China Fuwai Hospital of Zhengzhou Univers…
NCT07363538 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 di

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Neonates diagnosed with TAPVC, CoA/IAA, TGA, PA/IVS, or severe PS via pre-admission cardiac echocardiography; 2. Patients and families demonstrating high compliance, willing to sign informed consent forms and agree to complete one year of follow-up and related examinations. Exclusion Criteria: 1. Preterm infant (gestational age \< 36 weeks at birth); 2. Low birth weight (weight \< 2.5 kg); 3. Concurrent severe extracardiac anomalies or complex cardiac malformations; 4. Preoperative respiratory or circulatory instability requiring emergency surgery.
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What it tests

  • Surgical operation is performed on neonates aged >7 days (postnatal age)
  • Surgical operation is performed on neonates aged < 7 days (postnatal age).
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Where

12 sites
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China
Children's Hospital of Chongqing Medical University
Chongqing, China
Guangzhou Women and Children's Medical Center, Guangzhou Medical University
Guangzhou, China
Central China Fuwai Hospital of Zhengzhou University
Zhengzhou, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
The Second Xiangya Hospital of Central South University
Changsha, China
Children's Hospital Affiliated to Nanjing Medical University
Nanjing, China
Qingdao Women and Children's Hospital
Qingdao, China

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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