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

Central China Fuwai Hospital of Zhengzhou University

Status: Enrolling

Conditions: Complex Congenital Heart Disease

Treatments: 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

Funder types: Other

Identifiers

NCT07363538

2024ZD0527003

Details and patient eligibility

About

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.

Enrollment: 738 estimated patients

Sex: All

Ages: Under 7 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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738 participants in 2 patient groups

Control Group

Other group

Description:

Surgical operation is performed on neonates aged \>7 days (postnatal age)

Treatment:

Procedure: Surgical operation is performed on neonates aged >7 days (postnatal age)

Experimental Group

Experimental group

Description:

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

Treatment:

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