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NCT07363538
Multicenter Randomized Controlled Trial (RCT) and Efficacy Evaluation System Study on Surgical Innovation Strategies for Neonatal Complex Congenital Heart Disease
NA trial testing Surgical operation is performed on neonates aged >7 days (postnatal age) in Complex Congenital Heart Disease in 738 participants. Currently enrolling.
31 January 2029
Quick facts
| Lead sponsor | Central China Fuwai Hospital of Zhengzhou University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 738 |
| Start date | 1 December 2025 |
| Primary completion | 31 January 2029 |
| Estimated completion | 31 January 2029 |
| Sites | 12 locations across China |
Drugs / interventions tested
- Surgical operation is performed on neonates aged >7 days (postnatal age)
- Surgical operation is performed on neonates aged < 7 days (postnatal age).
Conditions studied
- Complex Congenital Heart Disease — all drugs for Complex Congenital Heart Disease →
Sponsor
Central China Fuwai Hospital of Zhengzhou University
Who can join
Under 7 Days, any sex, with Complex Congenital Heart Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07363538
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Complex Congenital Heart Disease
Currently open trials in the same condition.
- NCT06884046 — Support for the Management of Parental Stress in Surgical Resuscitation of Congenital Heart Diseases · NA · recruiting
- NCT07524998 — A Chinese Multicenter Study on Surgical Techniques and Outcomes Across the Lifespan in Congenital Heart Disease · recruiting
Other Central China Fuwai Hospital of Zhengzhou University trials
Trials by the same sponsor.
- NCT07113769 — Plasma Biomarkers and Platelet Morphology of Extracorporeal CardioPulmonary Resuscitation · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07363538 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Central China Fuwai Hospital of Zhengzhou University
- Last refreshed: 23 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07363538.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing