Early versus later corrective surgery for newborns with Tetralogy of Fallot.
A Multi-center, Randomized, Controlled Investigation of Tetralogy of Fallot in Neonates
This trial will test whether doing corrective heart surgery within the first 28 days or waiting until 3–6 months leads to better outcomes for newborns with Tetralogy of Fallot.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 1 Minute to 6 Months |
| Sex | All |
| Sponsor | Beijing Anzhen Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06822400 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Full-term neonates (≤28 days old) with a clinical diagnosis of Tetralogy of Fallot, birth weight over 2.5 kg, and parental informed consent are the ideal candidates.
Not a fit: Preterm infants, those with complex or single-ventricle cardiac anomalies, severe pulmonary artery hypoplasia, major genetic or extracardiac conditions, or infants requiring palliative care are unlikely to benefit from this trial's timing comparison.
Why it matters
Potential benefit: If successful, selecting the better timing for repair could reduce early deaths and complications and improve short-term recovery and growth for infants with TOF.
How similar studies have performed: Previous observational and smaller randomized studies of neonatal versus later TOF repair have shown mixed results—some report higher early surgical risk while others suggest reduced cyanotic events—so this randomized comparison seeks stronger evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality
- Beijing Anzhen Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Qiang Wang Prof Beijing Anzhen Hospital,Capital Medical University
- Email: wq.cory@163.com
- Phone: 8613811548581
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.