Tetralogy of Fallot
Conditions
Interventions
Experimental group:The child underwent surgical correction within 28 days after birth.
Control group:The infant receives surgical correction between 3 and 6 months after birth.
Sponsors
Beijing Anzhen Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Full-term neonates (gestational age 37–40 weeks) aged 2.5 kg. 3.Confirmed diagnosis of TOF. 4.Parental consent and signed informed consent form.
Exclusion criteria
Exclusion criteria: 1.Preterm infants (gestational age 32–37 weeks). 2.Coexisting complex cardiac anomalies such as pulmonary atresia, double outlet right ventricle, or right ventricular hypoplasia. 3.Severe TOF with pulmonary artery hypoplasia (McGoon ratio <1.2, LVEDVI <30 mL/m^2), recurrent hypoxic episodes (oxygen saturation <75%), or conditions warranting palliative or single-ventricle repair. 4.Extra-cardiac anomalies, including genetic or chromosomal abnormalities. 5.Neonatal bronchopulmonary dysplasia. 6.Deteriorating conditions in the control group precluding surgery by 3 months of age. 7.Parental refusal to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint: Rate of re-intervention 12 months after surgery;Incidence of Treatment-Emergent Adverse Events(mortality); | — |
Countries
China
Contacts
Public ContactWang Qiang
Beijing Anzhen Hospital, Capital Medical University
Outcome results
None listed