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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Other | Surgical operation is performed on neonates aged >7 days (postnatal age) |
|
| Experimental Group | Experimental | Surgical operation is performed on neonates aged < 7 days (postnatal age) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical operation is performed on neonates aged >7 days (postnatal age) | Procedure | Surgical operation is performed on neonates aged >7 days (postnatal age) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative Mortality and Non-Rehabilitation Discharge Rate | From enrollment to 1 year after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Song Shubo Shubo Song | Contact | 13523535453 | songshubo2008@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100037 | China | |
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| Surgical operation is performed on neonates aged < 7 days (postnatal age). | Procedure | Surgical operation is performed on neonates aged < 7 days (postnatal age). |
|
| Children's Hospital of Chongqing Medical University |
| Not yet recruiting |
| Chongqing |
| Chongqing Municipality |
| China |
| Guangzhou Women and Children's Medical Center, Guangzhou Medical University | Not yet recruiting | Guangzhou | Guangdong | China |
| Central China Fuwai Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450000 | China |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | China |
| The Second Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | China |
| Children's Hospital Affiliated to Nanjing Medical University | Not yet recruiting | Nanjing | Jiangsu | 210008 | China |
| Qingdao Women and Children's Hospital | Not yet recruiting | Qingdao | Shandong | 266000 | China |
| Shanghai Children's Medical Center (SCMC) Affiliated to Shanghai Jiao Tong University School of Medicine | Not yet recruiting | Shanghai | Shanghai Municipality | China |
| The First Affiliated Hospital of Air Force Medical University (Xijing Hospital) | Not yet recruiting | Xi’an | Shanxi | China |
| West China Second Hospital of Sichuan University | Not yet recruiting | Chengdu | Sichuan | China |
| Children's Hospital Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D000375 | Aging |
| ID | Term |
|---|---|
| D048788 | Growth and Development |
| D010829 | Physiological Phenomena |
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