Neonatal Transcatheter Cardiac Interventions at Sohag University Hospital

Study Overview
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Brief Summary
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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
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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; Balloon atrial septostomy. PDA stent implantation. Pulmonary valvuloplasty. Aortic valvuloplasty. Balloon angioplasty of coarctation. 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.

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

Conditions
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Transcatheter Neonatal Cardiac Interventions

Intervention / Treatment
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* Procedure: transcatheter cardiac intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neonates with critical congenital heart diseases that require early intervention Exclusion Criteria: Untreated sepsis and coagulopathy.

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Neonates with congenital heart disease<br>Neonates with critical congenital heart diseases that require early catheter intervention | Procedure: transcatheter cardiac intervention<br>* Balloon atrial septostomy, PDA stent implantation, Pulmonary valvuloplasty, Aortic valvuloplasty, Balloon angioplasty of coarctation, PDA closure in preterm neonates<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedure related complications | complications that may occur during or after procedure | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprocedure NICU admission | complications after procedure in NICU | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheter, neonates, congenital heart disease