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

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.

Study Overview

• Status: Recruiting
• Conditions: Complex Congenital Heart Disease
• Intervention / Treatment: Procedure: Surgical operation is performed on neonates aged >7 days (postnatal age); Procedure: Surgical operation is performed on neonates aged < 7 days (postnatal age).

• Study Type: Interventional
• Enrollment (Estimated): 738
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Song Shubo Shubo Song; Phone Number: 13523535453; Email: songshubo2008@126.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100037
      • Recruiting
      • Fuwai Hospital, Chinese Academy of Medical Sciences
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China
      • Not yet recruiting
      • Children's Hospital of Chongqing Medical University
  • Guangdong
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Guangzhou Women and Children's Medical Center, Guangzhou Medical University
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • Central China Fuwai Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China
      • Not yet recruiting
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • Not yet recruiting
      • The Second Xiangya Hospital Of Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Not yet recruiting
      • Children's Hospital Affiliated to Nanjing Medical University
  • Shandong
    • Qingdao, Shandong, China, 266000
      • Not yet recruiting
      • Qingdao Women and Children's Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Not yet recruiting
      • Shanghai Children's Medical Center (SCMC) Affiliated to Shanghai Jiao Tong University School of Medicine
  • Shanxi
    • Xi’an, Shanxi, China
      • Not yet recruiting
      • The First Affiliated Hospital of Air Force Medical University (Xijing Hospital)
  • Sichuan
    • Chengdu, Sichuan, China
      • Not yet recruiting
      • West China Second Hospital of Sichuan University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Not yet recruiting
      • Children's Hospital ZheJiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control Group; Surgical operation is performed on neonates aged >7 days (postnatal age)	Procedure: Surgical operation is performed on neonates aged >7 days (postnatal age); Surgical operation is performed on neonates aged >7 days (postnatal age)
Experimental: Experimental Group; Surgical operation is performed on neonates aged < 7 days (postnatal age)	Procedure: Surgical operation is performed on neonates aged < 7 days (postnatal age).; Surgical operation is performed on neonates aged < 7 days (postnatal age).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Perioperative Mortality and Non-Rehabilitation Discharge Rate	From enrollment to 1 year after surgery

Collaborators and Investigators

• Sponsor: Central China Fuwai Hospital of Zhengzhou University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Phenomena; Growth and Development; Aging
• Other Study ID Numbers: 2024ZD0527003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No