Neonatal Transcatheter Cardiac Interventions at Sohag University Hospital

Sponsor

Sohag University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06126484

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Transcatheter Neonatal Cardiac Interventions	Procedure: transcatheter cardiac intervention	N/A

Detailed Description

This study includes neonates with critical congenital heart diseases that require early interventions Patients with untreated sepsis and coagulopathy are excluded.

Methods:

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Apr 30, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Neonates with congenital heart disease

Neonates with critical congenital heart diseases that require early catheter intervention

Procedure: transcatheter cardiac intervention

Balloon atrial septostomy, PDA stent implantation, Pulmonary valvuloplasty, Aortic valvuloplasty, Balloon angioplasty of coarctation, PDA closure in preterm neonates

Outcome Measures

Primary Outcome Measures

procedure related complications [1 day]
complications that may occur during or after procedure

Secondary Outcome Measures

Postprocedure NICU admission [2 weeks]
complications after procedure in NICU

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Hour to 30 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Neonates with critical congenital heart diseases that require early intervention

Exclusion Criteria:

Untreated sepsis and coagulopathy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sohag University	Sohag		Egypt	82511

Sponsors and Collaborators

Sohag University

Investigators

Principal Investigator: Somaia S Mahmoud, Master, Faculty of Medicine, Sohag University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Somia Sabry Mahmoud, Assistant lecturer of Pediatrics, Sohag University

ClinicalTrials.gov Identifier:

NCT06126484

Other Study ID Numbers:

Soh-Med-23-10-04MD

First Posted:

Nov 13, 2023

Last Update Posted:

Nov 13, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Somia Sabry Mahmoud, Assistant lecturer of Pediatrics, Sohag University

Catheter, neonates, congenital heart disease

Additional relevant MeSH terms:

Heart Diseases

Heart Defects, Congenital

Study Results

No Results Posted as of Nov 13, 2023