Status:
RECRUITING
An Integrated Prenatal and Postnatal Treatment Model for the Treatment of Newborns With Critical Congenital Heart Disease
Lead Sponsor:
Beijing Anzhen Hospital
Collaborating Sponsors:
Capital Institute of Pediatrics, China
307 Hospital of PLA
Conditions:
Congenital Heart Disease
Coarctation of Aorta
Eligibility:
All Genders
1-28 years
Brief Summary
The purpose of this two-way cohort study was to explore whether an integrated prenatal and postnatal treatment model for neonates with critical congenital heart disease (CCHD) could be effective in av...
Eligibility Criteria
Inclusion Criteria:
- Full-term infants (gestational age 37-40 weeks): age less than 28 days;
- Preterm infants (gestational age greater than 32 weeks but less than 37 weeks): corrected gestational age as neonatal period, age less than 28 days;
- Birth weight > 1.5 kg;
- Fetal diagnosis of congenital heart diseases by ultrasound at 22-26 weeks of gestation, suitable for biventricular repair.
Exclusion Criteria:
- Only suitable for palliative surgery or single ventricle repair;
- Associated genetic/chromosomal abnormalities;
- Associated with other severe systemic diseases.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT06768008
Start Date
January 1 2022
End Date
December 31 2030
Last Update
January 10 2025
Active Locations (1)
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1
Biejing Anzhen Hospital
Beijing, China