Investigation of Tetralogy of Fallot in Neonates

Launched by BEIJING ANZHEN HOSPITAL · Feb 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the best timing and methods for repairing a heart condition called Tetralogy of Fallot (TOF) in newborns. TOF is a serious congenital heart defect that affects how blood flows through the heart, leading to low oxygen levels and other health problems. The trial aims to compare outcomes for babies who have the surgical repair done within the first month of life versus those who have it done later. The goal is to find the safest and most effective approach to improve survival rates and quality of life for children with TOF.

To participate in this trial, babies must be full-term newborns, diagnosed with TOF, and weigh over 2.5 kg (about 5.5 pounds). Unfortunately, preterm infants or those with more complex heart issues will not be eligible. Parents who choose to participate can expect their child to receive specialized care during the trial, and they will be monitored closely to ensure their safety throughout the process. This study is an important step towards improving future treatments for TOF, helping doctors understand the best ways to support these young patients.

Gender

ALL

Eligibility 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.