Study Results
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Basic Information
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RECRUITING
NA
160 participants
INTERVENTIONAL
2025-03-01
2028-01-31
Brief Summary
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Tetralogy of Fallot (TOF), the most common form of CCHD, accounts for a substantial proportion of cyanotic congenital heart diseases. It is characterized by four anatomical abnormalities: ventricular septal defect, pulmonary stenosis, overriding aorta, and right ventricular hypertrophy. These structural defects disrupt intracardiac blood flow, reduce arterial oxygen saturation, and result in cyanosis and other related symptoms. Untreated TOF leads to significant health issues early in life, including growth retardation, recurrent hypoxic episodes, heart failure, and increased susceptibility to infections. Long-term survival is markedly reduced, with only a small proportion surviving into adulthood. Thus, surgical intervention is pivotal for improving outcomes in TOF(Tetralogy of Fallot) patients.
Despite advances in medical technology yielding satisfactory early outcomes, long-term prognosis following TOF correction remains a challenge. Historically, surgical strategies emphasized complete relief of right ventricular outflow tract obstruction, often at the expense of pulmonary valve function. Recent studies, however, highlight the critical role of preserving pulmonary valve function in improving long-term outcomes, as pulmonary valve dysfunction is a leading cause of late right ventricular failure and reintervention. Additionally, surgical approaches, whether via atrial or ventricular access, have inherent advantages and limitations, but neither can fully eliminate the risk of postoperative arrhythmias associated with TOF's anatomical complexity and surgical impact. These issues underscore the necessity for further advancements in long-term management strategies.
Surgical correction of TOF in a single-stage procedure has become standard practice, with the timing of surgery progressively shifting to earlier ages-from school age in the 1990s to the current standard of 3-6 months of age. This timing ensures sufficient weight and organ maturity to withstand the complexities of cardiac surgery. However, in clinical practice, significant challenges persist, including: (1) Deterioration during the waiting period, during which patients may experience recurrent hypoxic episodes, inadequate weight gain, and exacerbated pulmonary vascular underdevelopment, thereby complicating definitive surgery and increasing perioperative risk. (2) Developmental delays due to chronic hypoxemia and heart failure, potentially leading to neurological deficits and pulmonary hypertension, adversely affecting cognitive and motor development. Neonatal repair, performed within 28 days of life, may mitigate these challenges by restoring normal circulatory physiology at the earliest possible stage.
International guidelines endorse neonatal TOF repair for capable centers, citing the potential for enhanced clinical benefits and superior prognoses. Clinical observations at our center indicate several advantages of neonatal TOF repair, including reduced intraoperative bleeding, cleaner surgical fields, and better pulmonary vascular development. These benefits may be attributed to the regenerative potential of neonatal myocardial cells and the absence of prolonged pathological circulatory states, which otherwise exacerbate anatomical abnormalities. Early intervention may reduce right ventricular fibrosis and pulmonary vascular pathology, thereby improving long-term outcomes.
With advancements in surgical techniques and perioperative care, neonatal TOF repair has become a routine practice at our center, with over 100 cases performed annually for two consecutive years. This success is supported by an integrated prenatal-to-postnatal care model, establishing a comprehensive treatment framework.
Given this context, the investigators propose a multicenter, randomized controlled trial (RCT) to compare the safety and efficacy of neonatal and infant TOF repair. This study aims to provide high-quality evidence for clinical practice, determine optimal surgical timing, and enhance overall survival rates and quality of life for TOF patients.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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intervention group
corrective surgery within 28 days of birth
Participants will be randomized into two groups with a 1:1 allocation:
Intervention Group: Neonates undergoing surgical correction of TOF within 28 days of birth.
control group
corrective surgery between 3-6 months of age
Participants will be randomized into two groups with a 1:1 allocation:
Control Group: Infants undergoing surgical correction of TOF between 3-6 months of age
Interventions
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corrective surgery within 28 days of birth
Participants will be randomized into two groups with a 1:1 allocation:
Intervention Group: Neonates undergoing surgical correction of TOF within 28 days of birth.
corrective surgery between 3-6 months of age
Participants will be randomized into two groups with a 1:1 allocation:
Control Group: Infants undergoing surgical correction of TOF between 3-6 months of age
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
1 Minute
6 Months
ALL
No
Sponsors
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Children's Hospital of Fudan University
OTHER
Suzhou University Affiliated Children's Hospital
OTHER
Shenzhen Children's Hospital
OTHER_GOV
West China Second University Hospital
OTHER
Beijing Anzhen Hospital
OTHER
Responsible Party
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Locations
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Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Qiang Wang Prof Beijing Anzhen Hospital,Capital Medical University
Role: CONTACT
Facility Contacts
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Qiang Wang MD Beijing Anzhen Hospital,Capital Medical University
Role: primary
Other Identifiers
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20241226
Identifier Type: -
Identifier Source: org_study_id
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