NCT07363538

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
738

participants targeted

Target at P75+ for not_applicable

Timeline
34mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Dec 2025Jan 2029

Study Start

First participant enrolled

December 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2029

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

3.2 years

First QC Date

January 15, 2026

Last Update Submit

January 15, 2026

Conditions

Complex Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Perioperative Mortality and Non-Rehabilitation Discharge Rate

    From enrollment to 1 year after surgery

Study Arms (2)

Control Group

OTHER

Surgical operation is performed on neonates aged \>7 days (postnatal age)

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)

Procedure: Surgical operation is performed on neonates aged < 7 days (postnatal age).

Interventions

Surgical operation is performed on neonates aged < 7 days (postnatal age).PROCEDURE

Surgical operation is performed on neonates aged \< 7 days (postnatal age).

Experimental Group

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, 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

Central China Fuwai Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

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

Children's Hospital Affiliated to Nanjing Medical University

Nanjing, Jiangsu, 210008, China

NOT YET RECRUITING

Qingdao Women and Children's Hospital

Qingdao, Shandong, 266000, China

NOT YET RECRUITING

Shanghai Children's Medical Center (SCMC) Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

The First Affiliated Hospital of Air Force Medical University (Xijing Hospital)

Xi’an, Shanxi, China

NOT YET RECRUITING

West China Second Hospital of Sichuan University

Chengdu, Sichuan, China

NOT YET RECRUITING

Children's Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

NOT YET RECRUITING

MeSH Terms

Interventions

Aging

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological Phenomena

Central Study Contacts

Song Shubo Shubo Song

CONTACT

13523535453songshubo2008@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
postgraduate student

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 23, 2026

Study Start

December 1, 2025

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

January 31, 2029

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

CN(12)