Transcatheter cardiac interventions for neonates with congenital heart disease
Outcomes of Transcatheter Cardiac Interventions in Neonates With Congenital Heart Disease at Sohag University Hospital
This study tests if certain heart procedures can safely help newborns with serious heart problems at Sohag University Hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 1 Hour to 30 Days |
| Sex | All |
| Sponsor | Sohag University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Sohag) |
| Trial ID | NCT06126484 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of transcatheter cardiac interventions in neonates diagnosed with critical congenital heart disease at Sohag University Hospital. It includes procedures such as balloon atrial septostomy, PDA stent implantation, and valvuloplasty, all performed under general anesthesia. Clinical and echocardiographic data will be collected to assess outcomes, and patients will receive post-procedure care in the NICU. The study aims to provide early intervention for neonates who require it urgently.
Who should consider this trial
Good fit: Ideal candidates for this study are neonates diagnosed with critical congenital heart diseases requiring early intervention.
Not a fit: Patients with untreated sepsis or coagulopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve survival rates and outcomes for neonates with critical congenital heart disease.
How similar studies have performed: Other studies have shown promising results with transcatheter interventions in similar populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Neonates with critical congenital heart diseases that require early intervention Exclusion Criteria: * Untreated sepsis and coagulopathy.
Where this trial is running
Sohag
- Sohag University — Sohag, Egypt (Recruiting)
Study contacts
- Principal investigator: Somaia S Mahmoud, Master — Faculty of Medicine, Sohag University
- Study coordinator: Somaia S Mahmoud, Master
- Email: somaia_sabry922@yahoo.com
- Phone: 201019052097
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.