Actively Recruiting
A Multi-center, Randomized, Controlled Investigation of Tetralogy of Fallot in Neonates
Led by Beijing Anzhen Hospital · Updated on 2025-09-10
160
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Beijing Anzhen Hospital
Lead Sponsor
C
Children's Hospital of Fudan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Child health is essential for overall public health, and neonatal mortality is a key indicator of a nation's health standards. In China, congenital heart disease (CHD) is the most common birth defect, with about 70,000-80,000 newborns affected yearly, including nearly 10,000 with critical congenital heart disease (CCHD). Tetralogy of Fallot (TOF), a major form of CCHD, causes serious heart defects that lead to low oxygen levels and life-threatening symptoms, requiring surgical repair to improve survival and quality of life. Despite advances, long-term outcomes after TOF surgery still present challenges, especially related to preserving pulmonary valve function and reducing heart rhythm problems.
CONDITIONS
Brief Title
Investigation of Tetralogy of Fallot in Neonates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of Tetralogy of Fallot
- Full-term neonates aged 28 days or less
- Birth weight greater than 2.5 kilograms
- Male or female patients
- Ability to provide informed consent
You will not qualify if you...
- Preterm infants
- Presence of complex cardiac anomalies
- Severe Tetralogy of Fallot with pulmonary artery underdevelopment or recurring low oxygen episodes
- Conditions requiring palliative or single-ventricle repair
- Genetic or chromosomal abnormalities
- Neonatal bronchopulmonary dysplasia
- Worsening condition preventing surgery by 3 months of age in the control group
- Parental refusal to participate in the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days
Participants undergo corrective surgery for Tetralogy of Fallot either within 28 days of birth or between 3-6 months of age, followed by immediate post-operative care.
Approximately 6 post-operative visits
Duration - Up to 3 years
Participants are monitored for surgical complications, cardiac related indicators, and other follow-up assessments after surgery.
Regular follow-up visits over 3 years
Trial Site Locations
Total: 1 location
1
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China, 100013
Actively Recruiting
Research Team
Q
Qiang Wang Prof Beijing Anzhen Hospital,Capital Medical University
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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