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NCT Number: NCT07363538

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

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.

Recruiting

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Key information

Conditions

Complex Congenital Heart Disease

Age range

Up to 7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Neonates diagnosed with TAPVC, CoA/IAA, TGA, PA/IVS, or severe PS via pre-admission cardiac echocardiography;
  • 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

  • Preterm infant (gestational age < 36 weeks at birth);
  • Low birth weight (weight < 2.5 kg);
  • Concurrent severe extracardiac anomalies or complex cardiac malformations;
  • Preoperative respiratory or circulatory instability requiring emergency surgery.

Treatment and study plan

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).

Procedure

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

Primary outcomes

  1. Perioperative Mortality and Non-Rehabilitation Discharge Rate

    Time frame: From enrollment to 1 year after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Song Shubo Shubo Song

CONTACT

[email protected]

13523535453

Sponsors and collaborators

Lead sponsor

Central China Fuwai Hospital of Zhengzhou University

Other

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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