NCT07363538

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 738 (estimated)
• Sponsor: Central China Fuwai Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 7 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Complex Congenital Heart Disease

Interventions

Type	Name	Description
PROCEDURE	Surgical operation is performed on neonates aged >7 days (postnatal age)	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).

Timeline

• Start date: 2025-12-01
• Primary completion: 2029-01-31
• Completion: 2029-01-31
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

12 sites across 1 country: China