Primary repair during the neonatal period for tetralogy of Fallot (RIFAN): a multicentre randomised controlled trial protocol in China

Introduction For clinically stable infants with tetralogy of Fallot (TOF), complete repair at 3–6 months is commonly recommended but the comparative effects of elective neonatal repair remain uncertain. Observational comparisons are vulnerable to confounding because infants repaired early often have more severe disease. The RIFAN trial will compare planned neonatal and infant repair in a randomised design. Methods and analysis This prospective, multicentre, open-label trial will enrol 160 term neonates aged ≤28 days with isolated TOF at five paediatric cardiac centres in China. Participants will be randomised 1:1 to complete repair at ≤28 days or at 3–6 months. The co-primary outcomes are all-cause death within 30 days after surgery, regardless of discharge status and therapeutic cardiac reintervention within 12 months after surgery, excluding procedures during the index hospitalisation. The respective non-inferiority margins are 7.5 and 10 percentage points. Secondary outcomes include perioperative morbidity, cardiac function, growth, neurodevelopment, healthcare use and longer-term survival. The planned sample of 80 participants per group was calculated to provide 80% power for each co-primary outcome separately under the stated assumptions. A supportive 12-month analysis beginning at randomisation will report death and unplanned therapeutic cardiac intervention. Analyses will follow randomised allocation, with a per-protocol sensitivity analysis. Ethics and dissemination The protocol was approved by the Medical Ethics Committee of Beijing Anzhen Hospital, Capital Medical University, on 1 March 2025 (reference number: Ethical Review 2025(5)). Each participating centre obtained approval from its hospital ethics committee before enrolling its first participant. The findings will be disseminated through peer-reviewed publications and presentations at scientific conferences. Trial registration number NCT06822400 (first submitted 2 January 2025; first posted 12 February 2025).