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Study identifier: NCT07363538 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Complex Congenital Heart Disease  ·  Sponsor: Central China Fuwai Hospital of Zhengzhou University

PhaseNA
Planned participants738
Who can joinAll sexes, N/A to 7 Days
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Song Shubo Shubo Song  ·  13523535453  ·  songshubo2008@126.com

Always discuss trial participation with your own doctor first.

Locations (12)

Fuwai Hospital, Chinese Academy of Medical SciencesBeijing, Beijing Municipality, ChinaRecruiting
Children's Hospital of Chongqing Medical UniversityChongqing, Chongqing Municipality, ChinaNot Yet Recruiting
Guangzhou Women and Children's Medical Center, Guangzhou Medical UniversityGuangzhou, Guangdong, ChinaNot Yet Recruiting
Central China Fuwai Hospital of Zhengzhou UniversityZhengzhou, Henan, ChinaRecruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, Hubei, ChinaNot Yet Recruiting
The Second Xiangya Hospital of Central South UniversityChangsha, Hunan, ChinaNot Yet Recruiting
Children's Hospital Affiliated to Nanjing Medical UniversityNanjing, Jiangsu, ChinaNot Yet Recruiting
Qingdao Women and Children's HospitalQingdao, Shandong, ChinaNot Yet Recruiting
Shanghai Children's Medical Center (SCMC) Affiliated to Shanghai Jiao Tong University School of MedicineShanghai, Shanghai Municipality, ChinaNot Yet Recruiting
The First Affiliated Hospital of Air Force Medical University (Xijing Hospital)Xi’an, Shanxi, ChinaNot Yet Recruiting
West China Second Hospital of Sichuan UniversityChengdu, Sichuan, ChinaNot Yet Recruiting
Children's Hospital Zhejiang University School of MedicineHangzhou, Zhejiang, ChinaNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT07363538