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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Day to 28 Days |
| Sex | All |
| Enrollment | 10000 (estimated) |
| Sponsor | Beijing Anzhen Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | January 1, 2022 |
| Main results expected | December 31, 2030 |
| Study ends | December 31, 2030 |
| Registry record updated | January 10, 2025 |
| Trial ID | NCT06768008 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
- Study coordinator: Lizhi Lv, MD
- Email: prolvlizhi@126.com
- Phone: 86+ 18800167531
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Evaluating the effectiveness of SGLT2 inhibitors in adults with congenital heart disease
This study is trying to see if a new type of diabetes medication can help adults with congenital heart disease feel better and manage their heart failure symptoms.
-
Monitoring oxygen levels in newborns with congenital heart defects
This study is testing a new way to monitor oxygen levels in newborns with congenital heart defects to see how it can help doctors understand their heart and blood flow better.
-
High intensity interval training for patients with congenital heart defects
This study is testing if a 12-week home workout program can help young people with certain heart defects exercise better and feel stronger.
-
Evaluation of the MASA Valve for heart surgery in children
This study is testing a new heart valve designed for children with certain heart defects to see if it is safe and helps improve their heart function.
-
Long-term safety follow-up after autologous cardiac stem cells in kids with single ventricle heart disease
This study checks whether autologous cardiac stem cells (JRM-001) remain safe for up to a year in children who already received them after heart reconstructive surgery.
-
Improving fitness for adolescents with the Fontan circulation
This study will test whether a home-based digital exercise program helps 10–17-year-olds with the Fontan circulation become more active and improve fitness compared with enhanced usual care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.