Multicenter Randomized Controlled Trial (RCT) and Efficacy Evaluation System Study on Surgical Innovation Strategies for Neonatal Complex Congenital Heart Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surgical operation is performed on neonates aged >7 days (postnatal age), Surgical operation is performed on neonates aged < 7 days (postnatal age)..
- Who it may be relevant to
- Registry conditions: Complex Congenital Heart Disease. Basic parameters: up to 7 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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).
Primary outcome measures
- Perioperative Mortality and Non-Rehabilitation Discharge Rate [Time frame: From enrollment to 1 year after surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 12 centers
- Fuwai Hospital, Chinese Academy of Medical Sciences — Beijing
- Children's Hospital of Chongqing Medical University — Chongqing
- Guangzhou Women and Children's Medical Center, Guangzhou Medical University — Guangzhou
- Central China Fuwai Hospital of Zhengzhou University — Zhengzhou
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
- The Second Xiangya Hospital of Central South University — Changsha
- Children's Hospital Affiliated to Nanjing Medical University — Nanjing
- Qingdao Women and Children's Hospital — Qingdao
- … and 4 more centers
Identifiers
NCT: NCT07363538 · 2024ZD0527003