Early versus later corrective surgery for newborns with Tetralogy of Fallot.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional trial compares two timing strategies for corrective repair of Tetralogy of Fallot in neonates: corrective surgery within 28 days of birth versus corrective surgery at 3–6 months of age. Full-term infants with a clinical diagnosis of TOF and birth weight >2.5 kg whose parents give informed consent are enrolled, while preterm infants, those with complex cardiac or major extracardiac anomalies, or severe pulmonary artery hypoplasia are excluded. Participants are treated primarily at Beijing Anzhen Hospital with collaborating pediatric centers and followed for perioperative outcomes, survival, complications, need for reintervention, and early growth and developmental measures. The trial aims to provide clearer evidence about the optimal timing of corrective repair to guide clinical decision-making for affected newborns.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Anzhen Hospital
  Beijing, Beijing Municipality, China Recruiting
• West China Second Hospital of Sichuan University
  Chengdu, China Recruiting
• The Children's Hospital of Fudan University, Shanghai
  Shanghai, China Recruiting
• Shenzhen Children's Hospital
  Shenzhen, China Recruiting
• Children's Hospital of Soochow University, Suzhou
  Suzhou, China Recruiting

Study contacts

• Study coordinator: Qiang Wang Prof Beijing Anzhen Hospital,Capital Medical University
• Email: wq.cory@163.com
• Phone: 8613811548581

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.