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Clinical Trials/NCT06126484
NCT06126484
Recruiting
Not Applicable

Outcomes of Transcatheter Cardiac Interventions in Neonates With Congenital Heart Disease at Sohag University Hospital

Sohag University1 site in 1 country30 target enrollmentApril 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Transcatheter Neonatal Cardiac Interventions
Sponsor
Sohag University
Enrollment
30
Locations
1
Primary Endpoint
procedure related complications
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
April 30, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Somia Sabry Mahmoud

Assistant lecturer of Pediatrics

Sohag University

Eligibility Criteria

Inclusion Criteria

  • Neonates with critical congenital heart diseases that require early intervention

Exclusion Criteria

  • Untreated sepsis and coagulopathy.

Outcomes

Primary Outcomes

procedure related complications

Time Frame: 1 day

complications that may occur during or after procedure

Secondary Outcomes

  • Postprocedure NICU admission(2 weeks)

Study Sites (1)

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