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Multicenter Randomized Controlled Trial (RCT) and Efficacy Evaluation System Study on Surgical Innovation Strategies for Neonatal Complex Congenital Heart Disease
Sponsor: Central China Fuwai Hospital of Zhengzhou University
Summary
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.
Key Details
Gender
All
Age Range
Any - 7 Days
Study Type
INTERVENTIONAL
Enrollment
738
Start Date
2025-12-01
Completion Date
2029-01-31
Last Updated
2026-01-23
Healthy Volunteers
No
Conditions
Interventions
Surgical operation is performed on neonates aged >7 days (postnatal age)
Surgical operation is performed on neonates aged \>7 days (postnatal age)
Surgical operation is performed on neonates aged < 7 days (postnatal age).
Surgical operation is performed on neonates aged \< 7 days (postnatal age).
Locations (12)
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Guangzhou Women and Children's Medical Center, Guangzhou Medical University
Guangzhou, Guangdong, China
Central China Fuwai Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Children's Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, China
Qingdao Women and Children's Hospital
Qingdao, Shandong, China
Shanghai Children's Medical Center (SCMC) Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Air Force Medical University (Xijing Hospital)
Xi’an, Shanxi, China
West China Second Hospital of Sichuan University
Chengdu, Sichuan, China
Children's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China