Actively Recruiting
Multicenter Randomized Controlled Trial (RCT) and Efficacy Evaluation System Study on Surgical Innovation Strategies for Neonatal Complex Congenital Heart Disease
Led by Central China Fuwai Hospital of Zhengzhou University · Updated on 2026-01-23
738
Participants Needed
12
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multicenter Randomized Controlled Trial (RCT) and Efficacy Evaluation System Study on Surgical Innovation Strategies for Neonatal Complex Congenital Heart Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neonates diagnosed with TAPVC, CoA/IAA, TGA, PA/IVS, or severe PS by cardiac echocardiography before admission
- Patients and families able to follow study procedures, willing to sign informed consent, and agree to complete one year of follow-up and related exams
You will not qualify if you...
- Preterm infants born before 36 weeks of gestation
- Low birth weight below 2.5 kg
- Severe extracardiac anomalies or complex cardiac malformations
- Respiratory or circulatory instability before surgery requiring emergency operation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
2
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Not Yet Recruiting
3
Guangzhou Women and Children's Medical Center, Guangzhou Medical University
Guangzhou, Guangdong, China
Not Yet Recruiting
4
Central China Fuwai Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Actively Recruiting
5
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Not Yet Recruiting
6
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Not Yet Recruiting
7
Children's Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, China, 210008
Not Yet Recruiting
8
Qingdao Women and Children's Hospital
Qingdao, Shandong, China, 266000
Not Yet Recruiting
9
Shanghai Children's Medical Center (SCMC) Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
10
The First Affiliated Hospital of Air Force Medical University (Xijing Hospital)
Xi’an, Shanxi, China
Not Yet Recruiting
11
West China Second Hospital of Sichuan University
Chengdu, Sichuan, China
Not Yet Recruiting
12
Children's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Not Yet Recruiting
Research Team
S
Song Shubo Shubo Song
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here