Randomized Trial of Surgical Timing for Treating Newborns with Complex Congenital Heart Disease Evaluating Outcomes Within One Year After Surgery

What this Trial Is About

Researchers are conducting a multi-center randomized controlled trial to determine the best timing for surgery in newborns with Complex Congenital Heart Disease CCHD. The study aims to develop innovative treatment strategies for critically ill newborns with CCHD and establish a system to evaluate treatment effectiveness. The goal is to reduce perioperative death and non-recovery discharge rates by half, improving overall care standards for these newborns in China. The trial compares two surgical approaches operating on newborns younger than 7 days old and operating on those older than 7 days. Participants will be randomly assigned to one of these two groups. The study uses data from a national multi-center database and integrates prenatal and postnatal diagnosis to guide treatment. Newborns diagnosed with specific heart defects will be followed for one year after surgery. Researchers will monitor perioperative mortality and non-rehabilitation discharge rates. Participants and their families will complete related examinations and follow-up visits during this period to assess treatment outcomes and safety under medical supervision.

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