Clinical trial Recruiting at 1 site Observational Ages 1 Day to 28 Days

Integrated prenatal and postnatal treatment for newborns with critical congenital heart disease

Official title: Clinical Study of an Integrated Prenatal and Postnatal Treatment Model to Improve the Treatment Effect of Newborns With Critical Congenital Heart Disease

Run by Beijing Anzhen Hospital · NCT06768008 · Data updated 2026-11-12

This study is testing a new approach that combines care before and after birth for newborns with serious heart defects to see if it can improve their treatment and recovery.

More Congenital Heart Disease trials

Quick facts

Study typeObservational
Ages1 Day to 28 Days
SexAll
Enrollment10000 (estimated)
SponsorBeijing Anzhen Hospital
Academic / other
Locations1 site (Beijing)
StatusRecruiting
StartedJanuary 1, 2022
Main results expectedDecember 31, 2030
Study endsDecember 31, 2030
Registry record updatedJanuary 10, 2025
Trial IDNCT06768008 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include full-term and preterm infants diagnosed with congenital heart diseases suitable for biventricular repair.

Probably not a fit

Patients who are only suitable for palliative surgery or have associated genetic abnormalities may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate an integrated treatment model for neonates with critical congenital heart disease (CCHD) that combines prenatal and postnatal care. The approach focuses on minimizing preoperative morbidities, optimizing the timing for surgical interventions, and enhancing postoperative outcomes compared to traditional care models. Additionally, the study investigates the potential for myocardial regeneration through early postnatal cardiac surgery in neonates with right cardiac system involvement. The ultimate goal is to improve diagnostic and therapeutic strategies for CCHD and enhance healthcare services for affected patients.

Why it matters

Potential benefit: If successful, this approach could significantly reduce mortality and improve surgical outcomes for newborns with critical congenital heart disease.

How similar studies have gone: While integrated treatment models for congenital heart disease are being explored, this specific approach is novel and has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Full-term infants (gestational age 37-40 weeks): age less than 28 days;
2. Preterm infants (gestational age greater than 32 weeks but less than 37 weeks): corrected gestational age as neonatal period, age less than 28 days;
3. Birth weight \> 1.5 kg;
4. Fetal diagnosis of congenital heart diseases by ultrasound at 22-26 weeks of gestation, suitable for biventricular repair.

Exclusion Criteria:

1. Only suitable for palliative surgery or single ventricle repair;
2. Associated genetic/chromosomal abnormalities;
3. Associated with other severe systemic diseases.

Where it's running

  • Biejing Anzhen Hospital
    Beijing, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.