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Clinical Trial Summary

This study is performed to assess the safety, efficacy and outcome of transcatheter cardiac interventions in neonates with critical congenital heart disease at Sohag University Hospital


Clinical Trial Description

This study includes neonates with critical congenital heart diseases that require early interventions Patients with untreated sepsis and coagulopathy are excluded. Methods: A) Clinical data: age, body weight and oxygen saturation B) Echocardiographic data: cardiac anatomical diagnosis. C) Catheterization data: vascular access, description of the defects, type of the device used, fluoroscopy time, radiation time, related complications and added interventions in the same setting. D) Procedural details: - All procedures will be performed under general anesthesia. procedures will be performed are; 1. Balloon atrial septostomy. 2. PDA stent implantation. 3. Pulmonary valvuloplasty. 4. Aortic valvuloplasty. 5. Balloon angioplasty of coarctation. 6. PDA device closure for preterm neonates. E) Post-procedure details: - All the patients will be transferred to NICU. - Prophylactic antibiotic therapy will be given to all patients. - In patients with PDA stent; heparin infusion will be maintained for at least for 24-48 hours then acetylsalicylic acid: Dose; 5mg/kg/day will be added when oral feeding could be established until undergoing second-stage palliation or repair. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06126484
Study type Interventional
Source Sohag University
Contact Somaia S Mahmoud, Master
Phone 201019052097
Email somaia_sabry922@yahoo.com
Status Recruiting
Phase N/A
Start date April 1, 2023
Completion date April 30, 2025