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New trial aims to halve deaths in newborns with severe heart disease

NCT ID NCT07363538

Disease control Sponsor: Central China Fuwai Hospital of Zhengzhou University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares performing heart surgery on newborns with complex congenital heart disease either before or after 7 days of age. Researchers will track which timing leads to fewer deaths and better recovery. The trial involves 738 babies across multiple hospitals in China.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
surgical operation
What this could lead to
If successful, this could establish the best timing for life-saving heart surgery in newborns, potentially halving death and non-recovery rates.
What could go wrong
This is a large trial but still early in its evaluation. The optimal timing may vary by individual, and results may not apply to all hospitals or countries.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 738 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 7 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

aorta coarctation congenital heart disease congenital total pulmonary venous return anomaly conotruncal heart malformations pulmonary atresia-intact ventricular septum syndrome pulmonic stenosis transposition of the great arteries

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Complex congenital heart disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Central China Fuwai Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450000, China

  • Children's Hospital Affiliated to Nanjing Medical University

    NOT_YET_RECRUITING

    Nanjing, Jiangsu, 210008, China

  • Children's Hospital Zhejiang University School of Medicine

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, China

  • Children's Hospital of Chongqing Medical University

    NOT_YET_RECRUITING

    Chongqing, Chongqing Municipality, China

  • Fuwai Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100037, China

  • Guangzhou Women and Children's Medical Center, Guangzhou Medical University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, China

  • Qingdao Women and Children's Hospital

    NOT_YET_RECRUITING

    Qingdao, Shandong, 266000, China

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

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, China

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

    NOT_YET_RECRUITING

    Xi’an, Shanxi, China

  • The Second Xiangya Hospital of Central South University

    NOT_YET_RECRUITING

    Changsha, Hunan, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    NOT_YET_RECRUITING

    Wuhan, Hubei, China

  • West China Second Hospital of Sichuan University

    NOT_YET_RECRUITING

    Chengdu, Sichuan, China

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