Complex Congenital Heart DiseaseNCT07363538
Multicenter Randomized Controlled Trial (RCT) and Efficacy Evaluation System Study on Surgical Innovation Strategies for Neonatal Complex Congenital Heart Disease
A study testing Surgical operation is performed on neonates aged >7 days (postnatal age) and Surgical operation is performed on neonates aged < 7 days (postnatal age). in people with Complex Congenital Heart Disease, run by Central China Fuwai Hospital of Zhengzhou University at 12 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Complex Congenital Heart Disease
- What is being tested?
- Surgical operation is performed on neonates aged >7 days (postnatal age) and Surgical operation is performed on neonates aged < 7 days (postnatal age).
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 738 participants
- Where
- 12 sitesChina
- Study dates
- 1 Dec 2025to 31 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037
- Not yet recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan
- Not yet recruiting
West China Second Hospital of Sichuan University
Chengdu, Sichuan
- Not yet recruiting
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
- Not yet recruiting
Guangzhou Women and Children's Medical Center, Guangzhou Medical University
Guangzhou, Guangdong
- Not yet recruiting
Children's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
- Not yet recruiting
Children's Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, 210008
- Not yet recruiting
Qingdao Women and Children's Hospital
Qingdao, Shandong, 266000
- Not yet recruiting
Shanghai Children's Medical Center (SCMC) Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
- Not yet recruiting
The First Affiliated Hospital of Air Force Medical University (Xijing Hospital)
Xi’an, Shanxi
- Recruiting
Central China Fuwai Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
About this study
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.
- Conditions
- Complex Congenital Heart Disease
- Being tested
- Surgical operation is performed on neonates aged >7 days (postnatal age), Surgical operation is performed on neonates aged < 7 days (postnatal age).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical operation is performed on neonates aged >7 days (postnatal age)Procedure or surgery
Surgical operation is performed on neonates aged >7 days (postnatal age)
Surgical operation is performed on neonates aged < 7 days (postnatal age).Procedure or surgery
Surgical operation is performed on neonates aged < 7 days (postnatal age).
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | Surgical operation is performed on neonates aged >7 days (postnatal age) Receives: Procedure: 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) Receives: Procedure: Surgical operation is performed on neonates aged < 7 days (postnatal age). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative Mortality and Non-Rehabilitation Discharge Rate
Measured: From enrollment to 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Dec 2025
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 738 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central China Fuwai Hospital of Zhengzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qihang Yang, Central China Fuwai Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363538
- Sponsor's protocol ID
- 2024ZD0527003
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Trial (RCT) and Efficacy Evaluation System Study on Surgical Innovation Strategies for Neonatal Complex Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT07363538
- Acronym / sponsor ID
- 2024ZD0527003
- Conditions
- Complex Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 738 participants (estimated)
- Lead sponsor
- Central China Fuwai Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Procedure: Surgical operation is performed on neonates aged >7 days (postnatal age)Surgical operation is performed on neonates aged >7 days (postnatal age) |
| Experimental Group | Experimental | Procedure: Surgical operation is performed on neonates aged < 7 days (postnatal age).Surgical operation is performed on neonates aged < 7 days (postnatal age) |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical operation is performed on neonates aged >7 days (postnatal age)Surgical operation is performed on neonates aged >7 days (postnatal age) | Procedure or surgery | Control Group |
| Surgical operation is performed on neonates aged < 7 days (postnatal age).Surgical operation is performed on neonates aged < 7 days (postnatal age). | Procedure or surgery | Experimental Group |
Primary outcome
Perioperative Mortality and Non-Rehabilitation Discharge Rate
Time frame: From enrollment to 1 year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical operation is performed on neonates aged >7 days (postnatal age) and Surgical operation is performed on neonates aged < 7 days (postnatal age). in people with Complex Congenital Heart Disease, run by Central China Fuwai Hospital of Zhengzhou University at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Song Shubo Shubo Song (13523535453, songshubo2008@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Mortality and Non-Rehabilitation Discharge Rate (time frame: From enrollment to 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.