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Neonatal Transcatheter Cardiac Interventions at Sohag University Hospital

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06126484
Enrollment
30
Registered
2023-11-13
Start date
2023-04-01
Completion date
2025-04-30
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transcatheter Neonatal Cardiac Interventions

Keywords

Catheter, neonates, congenital heart disease

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.

Interventions

PROCEDUREtranscatheter cardiac intervention

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

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Hours to 30 Days
Healthy volunteers
No

Inclusion criteria

* Neonates with critical congenital heart diseases that require early intervention

Exclusion criteria

* Untreated sepsis and coagulopathy.

Design outcomes

Primary

MeasureTime frameDescription
procedure related complications1 daycomplications that may occur during or after procedure

Secondary

MeasureTime frameDescription
Postprocedure NICU admission2 weekscomplications after procedure in NICU

Countries

Egypt

Contacts

Primary ContactSomaia S Mahmoud, Master
somaia_sabry922@yahoo.com201019052097
Backup ContactSafaa H Ali, professor
201064818849

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026