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Investigation of Tetralogy of Fallot in Neonates

RecruitingNAAges 1 Minute - 6 MonthsAllBeijing Anzhen Hospital
NCT06822400 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Child health serves as the foundation for overall public health, with neonatal mortality recognized globally as a comprehensive indicator of national health standards and societal advancement. The Healthy Children Action Improvement Plan (2021-2025) sets a national target to reduce neonatal mortality in China to below 3.1‰. Congenital heart disease (CHD), the most prevalent congenital defect among neonates, constitutes a significant cause of disability and premature death in the Chinese population. Annually, approximately 70,000-80,000 neonates are born with CHD, among whom nearly 10,000 present with critical congenital heart disease (CCHD). Postnatal manifestations of CCHD often include cyanosis, hypoperfusion, and respiratory distress, with untreated cases resulting in approximately 50% mortality. CCHD is one of the leading causes of infant death. Tetralogy of Fallot (TOF), the most c

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📋 Eligibility rules (as published)
Inclusion Criteria: Clinical diagnosis of TOF's Disease. Full-term neonates aged ≤28 days. Birth weight of all eligible male or female patients \>2.5 kg. All included study participants must be able to give an informed consent Exclusion Criteria: Preterm infants . Coexisting complex cardiac anomalies. Severe TOF with pulmonary artery hypoplasia , recurrent hypoxic episodes , or conditions warranting palliative or single-ventricle repair. Extra-cardiac anomalies, including genetic or chromosomal abnormalities. Neonatal bronchopulmonary dysplasia. Deteriorating conditions in the control group precluding surgery by 3 months of age. Parental refusal to participate in the clinical trial.
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What it tests

  • corrective surgery within 28 days of birth
  • corrective surgery between 3-6 months of age
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Where

5 sites
Beijing Anzhen Hospital
Beijing, China
West China Second Hospital of Sichuan University
Chengdu, China
The Children's Hospital of Fudan University, Shanghai
Shanghai, China
Shenzhen Children's Hospital
Shenzhen, China
Children's Hospital of Soochow University, Suzhou
Suzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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