Prenatal-postnatal integrated management model improves outcomes of neonatal cardiac surgery in critical congenital heart disease: a retrospective cohort study.
Yuekun Sun, Yiping Han, Gang Li...
https://pubmed.ncbi.nlm.nih.gov/41491678Actively Recruiting
Age: 1Day - 28Days
All Genders
ID06768008
Clinical Study of an Integrated Prenatal and Postnatal Treatment Model to Improve the Treatment Effect of Newborns With Critical Congenital Heart Disease
Led by Beijing Anzhen Hospital · Updated on 2025-01-10
10000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Beijing Anzhen Hospital
Lead Sponsor
C
Capital Institute of Pediatrics, China
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether an integrated prenatal and postnatal treatment model improves outcomes for newborns with critical congenital heart disease (CCHD) compared to traditional care. This study aims to see if early diagnosis during pregnancy, combined with coordinated delivery and surgical planning, can reduce preoperative complications, optimize surgery timing, lower postoperative mortality, and enhance heart healing, especially in cases involving the right heart system. The goal is to improve treatment capacity and create guidelines suited to China's healthcare needs. The integrated model involves diagnosing CCHD by ultrasound at 22 to 26 weeks of pregnancy, transferring the mother within the hospital system before birth, and planning surgical care after multidisciplinary discussion. Newborns are transferred to the pediatric heart center immediately after birth for either urgent or elective surgery depending on their condition. Traditional care involves transferring newborns from outside hospitals with routine interventions. The study compares these two approaches by following patients from birth through surgery and afterward. Participants will be monitored during hospitalization, with evaluations of heart function, metabolic status, and survival rates over up to five years post-discharge. Researchers will assess 30-day postoperative mortality as the primary outcome and also look at heart failure before surgery, the proportion receiving integrated care, and long-term survival and reoperation rates. This real-world study uses hospital data from multiple sites to validate if the integrated prenatal-postnatal model offers better outcomes for newborns with CCHD.
CONDITIONS
Brief Title
An Integrated Prenatal and Postnatal Treatment Model for the Treatment of Newborns With Critical Congenital Heart Disease
Who Can Participate
Age: 1Day - 28Days
All Genders
Eligibility Criteria
You may qualify if you...
- Full-term infants (gestational age 37-40 weeks) younger than 28 days
- Preterm infants (gestational age 32-37 weeks) with corrected gestational age in the neonatal period, younger than 28 days
- Birth weight greater than 1.5 kg
- Fetal diagnosis of congenital heart diseases by ultrasound at 22-26 weeks, suitable for biventricular repair
You will not qualify if you...
- Only suitable for palliative surgery or single ventricle repair
- Presence of genetic or chromosomal abnormalities
- Associated with other severe systemic diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - From fetal diagnosis around 22-26 weeks of gestation until birth and neonatal period
Participants undergo integrated prenatal and postnatal diagnosis to assess critical congenital heart disease.
Monitoring
Duration - Approximately 1 week during hospital stay
Participants are observed during hospitalization to monitor heart condition and prepare for surgery.
During hospitalization (expected average of 1 week)
Long-term Monitoring
Duration - Up to 5 years after discharge
Participants are followed for medium- and long-term survival, re-operations, and health outcomes after discharge.
Follow-up visits up to 5 years post-discharge
Trial Site Locations
Total: 1 location
1
Biejing Anzhen Hospital
Beijing, China
Actively Recruiting
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Research Team
L
Lizhi Lv, MD
Q
Qiang Wang, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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