Neonatal Transcatheter Cardiac Interventions at Sohag University Hospital

Not Applicable

Recruiting

• Conditions: Transcatheter Neonatal Cardiac Interventions
• Interventions: Procedure: transcatheter cardiac intervention

• Registration Number: NCT06126484
• Lead Sponsor: Sohag University

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.

Study Timeline

• Study Start: 2023-04-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-06
• Study First Submitted QC: 2023-11-09
• Last Update Submitted: 2023-11-09
• Study First Posted: 2023-11-13
• Last Update Posted: 2023-11-13
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Neonates with critical congenital heart diseases that require early intervention

Exclusion Criteria

• Untreated sepsis and coagulopathy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neonates with congenital heart disease	transcatheter cardiac intervention	Neonates with critical congenital heart diseases that require early catheter intervention

Primary Outcome Measures

Name	Time	Method
procedure related complications	1 day	complications that may occur during or after procedure

Secondary Outcome Measures

Name	Time	Method
Postprocedure NICU admission	2 weeks	complications after procedure in NICU

Trial Locations

Locations (1)

Sohag University; 🇪🇬 Sohag, Egypt