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Clinical Trials in China / NCT07363538
Recruiting Not applicable

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

NCT07363538 · tracked via the Priya Life Science China tracker
Sponsor
Central China Fuwai Hospital of Zhengzhou University
Phase
Not applicable
Started
2025-12-01
Last updated
2026-01-23

Condition(s) studied

Complex Congenital Heart Disease

Investigational drug(s) / intervention(s)

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)

Surgical operation is performed on neonates aged < 7 days (postnatal age).: Surgical operation is performed on neonates aged \< 7 days (postnatal age).

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
7 Days
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Perioperative Mortality and Non-Rehabilitation Discharge Rate — From enrollment to 1 year after surgery

Trial sites (12)

FacilityCityRegionStatus
Fuwai Hospital, Chinese Academy of Medical Sciences Beijing Beijing Municipality Recruiting
Children's Hospital of Chongqing Medical University Chongqing Chongqing Municipality Not Yet Recruiting
Guangzhou Women and Children's Medical Center, Guangzhou Medical University Guangzhou Guangdong Not Yet Recruiting
Central China Fuwai Hospital of Zhengzhou University Zhengzhou Henan Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei Not Yet Recruiting
The Second Xiangya Hospital of Central South University Changsha Hunan Not Yet Recruiting
Children's Hospital Affiliated to Nanjing Medical University Nanjing Jiangsu Not Yet Recruiting
Qingdao Women and Children's Hospital Qingdao Shandong Not Yet Recruiting
Shanghai Children's Medical Center (SCMC) Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality Not Yet Recruiting
The First Affiliated Hospital of Air Force Medical University (Xijing Hospital) Xi’an Shanxi Not Yet Recruiting
West China Second Hospital of Sichuan University Chengdu Sichuan Not Yet Recruiting
Children's Hospital Zhejiang University School of Medicine Hangzhou Zhejiang Not Yet Recruiting

More Central China Fuwai Hospital of Zhengzhou University trials in China

Plasma Biomarkers and Platelet Morphology of Extracorporeal CardioPulmonary Resuscitation Recruiting

Other trials for the same condition

A Chinese Multicenter Study on Surgical Techniques and Outcomes Across the Lifespan in Congenital Heart Disease Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07363538 on ClinicalTrials.gov ↗ ← All trials in China