Optimal timing and treatment strategies for newborn complex congenital heart disease surgery

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

This project will test whether doing heart surgery within the first week of life versus after day seven leads to fewer deaths and complications for newborns with complex congenital heart defects.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 738 (estimated)
• Ages: N/A to 7 Days
• Sex: All
• Sponsor: Central China Fuwai Hospital of Zhengzhou University (Academic / other)
• Locations: 12 sites (Beijing, Beijing Municipality and 11 other locations)
• Trial ID: NCT07363538 on ClinicalTrials.gov

What this trial studies

This is a multicenter randomized controlled trial that will assign neonates with selected complex congenital heart defects to surgery either before day seven or after day seven of life. The trial builds on a national multicenter surgical database and a prenatal-postnatal integrated diagnosis and treatment model, and includes standardized perioperative protocols and one year of follow-up. The investigators will also develop comprehensive treatment strategies for critically ill neonatal patients and create an efficacy evaluation system based on trial data. The program intends to roll out the evaluation system nationwide to reduce perioperative mortality and non-recovery discharge rates.

Who should consider this trial

Good fit: Term neonates (≥36 weeks gestation) weighing ≥2.5 kg who are diagnosed by pre-admission echocardiography with TAPVC, CoA/IAA, TGA, PA/IVS, or severe PS and whose families consent to one year of follow-up are ideal candidates.

Not a fit: Preterm infants (<36 weeks), low-birth-weight babies (<2.5 kg), those with severe extracardiac anomalies or very complex cardiac malformations, or neonates needing emergency unstable preoperative support are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could substantially lower perioperative deaths and non-recovery discharges and raise the overall standard of neonatal CCHD care in China.

How similar studies have performed: Randomized trials directly comparing neonatal cardiac surgery timing are limited and prior evidence is mixed, so this large multicenter RCT represents a relatively novel approach.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 11 other locations

• Fuwai Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
• Children's Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• Guangzhou Women and Children's Medical Center, Guangzhou Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Central China Fuwai Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Not_yet_recruiting)
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• Children's Hospital Affiliated to Nanjing Medical University — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Qingdao Women and Children's Hospital — Qingdao, Shandong, China (Not_yet_recruiting)
• Shanghai Children's Medical Center (SCMC) Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• The First Affiliated Hospital of Air Force Medical University (Xijing Hospital) — Xi’an, Shanxi, China (Not_yet_recruiting)
• West China Second Hospital of Sichuan University — Chengdu, Sichuan, China (Not_yet_recruiting)
• Children's Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Song Shubo Shubo Song

Conditions Complex Congenital Heart Disease