Optimal timing and treatment strategies for newborn complex congenital heart disease surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter randomized controlled trial that will assign neonates with selected complex congenital heart defects to surgery either before day seven or after day seven of life. The trial builds on a national multicenter surgical database and a prenatal-postnatal integrated diagnosis and treatment model, and includes standardized perioperative protocols and one year of follow-up. The investigators will also develop comprehensive treatment strategies for critically ill neonatal patients and create an efficacy evaluation system based on trial data. The program intends to roll out the evaluation system nationwide to reduce perioperative mortality and non-recovery discharge rates.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fuwai Hospital, Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting
• Central China Fuwai Hospital of Zhengzhou University
  Zhengzhou, Henan, China Recruiting
• Children's Hospital of Chongqing Medical University
  Chongqing, Chongqing Municipality, China Not yet recruiting
• Guangzhou Women and Children's Medical Center, Guangzhou Medical University
  Guangzhou, Guangdong, China Not yet recruiting
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Not yet recruiting
• The Second Xiangya Hospital of Central South University
  Changsha, Hunan, China Not yet recruiting

Study contacts

• Study coordinator: Song Shubo Shubo Song
• Email: songshubo2008@126.com
• Phone: 13523535453

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.