Neonatal Transcatheter Cardiac Interventions at Sohag University Hospital
NCT ID: NCT06126484
Last Updated: 2023-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
30 participants
INTERVENTIONAL
2023-04-01
2025-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Characterization, Risk Factors and Outcome of Neonates Admitted to Neonatal Intensive Care Units (NICU) at Sohag University Hospitals
NCT05809063
The Efficacy of a Novel, Non-contact EKG in the NICU
NCT04269044
Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates
NCT05706428
Evaluation of Placental Transfusion Techniques in Prevention of Prematurity Related Complications and Effect on Their Hematological Profile
NCT06812507
Nasal vs. Oral Intubation for Neonates Requiring Cardiac Surgery
NCT05378685
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Neonates with congenital heart disease
Neonates with critical congenital heart diseases that require early catheter intervention
transcatheter cardiac intervention
Balloon atrial septostomy, PDA stent implantation, Pulmonary valvuloplasty, Aortic valvuloplasty, Balloon angioplasty of coarctation, PDA closure in preterm neonates
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
transcatheter cardiac intervention
Balloon atrial septostomy, PDA stent implantation, Pulmonary valvuloplasty, Aortic valvuloplasty, Balloon angioplasty of coarctation, PDA closure in preterm neonates
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
1 Hour
30 Days
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sohag University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Somia Sabry Mahmoud
Assistant lecturer of Pediatrics
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Somaia S Mahmoud, Master
Role: PRINCIPAL_INVESTIGATOR
Faculty of Medicine, Sohag University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sohag University
Sohag, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Safaa H Ali, professor
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Soh-Med-23-10-04MD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.