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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07363538

Enrollment

738

Registered

2026-01-23

Start date

2025-12-01

Completion date

2029-01-31

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex Congenital Heart Disease

Brief 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.

Interventions

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

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

PROCEDURESurgical operation is performed on neonates aged < 7 days (postnatal age).

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 7 Days

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.

Design outcomes

Primary

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

Countries

China

Contacts

CONTACTSong Shubo Shubo Song

songshubo2008@126.com13523535453

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026