Integrated prenatal and postnatal treatment for newborns with critical congenital heart disease
Clinical Study of an Integrated Prenatal and Postnatal Treatment Model to Improve the Treatment Effect of Newborns With Critical Congenital Heart Disease
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 |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 1 Day to 28 Days |
| Sex | All |
| Sponsor | Beijing Anzhen Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06768008 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include full-term and preterm infants diagnosed with congenital heart diseases suitable for biventricular repair.
Not a fit: Patients who are only suitable for palliative surgery or have associated genetic abnormalities may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Beijing
- Biejing Anzhen Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Lizhi Lv, MD
- Email: prolvlizhi@126.com
- Phone: 86+ 18800167531
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.