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NCT07363538

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

Recruiting now NA Last updated 23 January 2026
What this trial tests

NA trial testing Surgical operation is performed on neonates aged >7 days (postnatal age) in Complex Congenital Heart Disease in 738 participants. Currently enrolling.

Timeline
1 December 2025
Primary endpoint
31 January 2029
31 January 2029

Quick facts

Lead sponsorCentral China Fuwai Hospital of Zhengzhou University
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment738
Start date1 December 2025
Primary completion31 January 2029
Estimated completion31 January 2029
Sites12 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Central China Fuwai Hospital of Zhengzhou University

Who can join

Under 7 Days, any sex, with Complex Congenital Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Complex Congenital Heart Disease

Currently open trials in the same condition.

Other Central China Fuwai Hospital of Zhengzhou University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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