Transcatheter Neonatal Cardiac InterventionsNCT06126484
Neonatal Transcatheter Cardiac Interventions at Sohag University Hospital
A study testing transcatheter cardiac intervention in people with Transcatheter Neonatal Cardiac Interventions, run by Sohag University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 1 hour to 30 days
- Conditions the study is for
- Transcatheter Neonatal Cardiac Interventions
- What is being tested?
- transcatheter cardiac intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates with critical congenital heart diseases that require early intervention
Who cannot join
- Untreated sepsis and coagulopathy.
Trial locations and contacts
1 site in 1 country.
Safaa H Ali, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag, 82511
Somaia S Mahmoud, Master, 201019052097, somaia_sabry922@yahoo.com
About this study
Official title: Outcomes of Transcatheter Cardiac Interventions in Neonates With Congenital Heart Disease at Sohag University Hospital
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
Read the 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.
- 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.
- 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.
- Being tested
- transcatheter cardiac intervention
- Keywords
- Catheter, neonates, congenital heart disease
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcatheter cardiac interventionProcedure or surgery
Balloon atrial septostomy, PDA stent implantation, Pulmonary valvuloplasty, Aortic valvuloplasty, Balloon angioplasty of coarctation, PDA closure in preterm neonates
| Study group | Role | What they receive |
|---|---|---|
| Neonates with congenital heart disease | Other | Neonates with critical congenital heart diseases that require early catheter intervention Receives: Procedure: transcatheter cardiac intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
procedure related complications
complications that may occur during or after procedure
Measured: 1 day
Secondary outcomes (1)
Postprocedure NICU admission
complications after procedure in NICU
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Apr 2023
- Primary completion1 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Neonatal Cardiac InterventionsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Somia Sabry Mahmoud, Sohag University
- Investigators
- Somaia S Mahmoud, Master, Principal investigator, Faculty of Medicine, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126484
- Sponsor's protocol ID
- Soh-Med-23-10-04MD
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Transcatheter Cardiac Interventions in Neonates With Congenital Heart Disease at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT06126484
- Acronym / sponsor ID
- Soh-Med-23-10-04MD
- Keywords
- Catheter, neonates, congenital heart disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates with congenital heart disease | Other | Procedure: transcatheter cardiac interventionNeonates with critical congenital heart diseases that require early catheter intervention |
Who may qualify
- Ages
- 1 hour to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Neonates with critical congenital heart diseases that require early intervention
Key exclusion criteria (1 listed)
- Untreated sepsis and coagulopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcatheter cardiac interventionBalloon atrial septostomy, PDA stent implantation, Pulmonary valvuloplasty, Aortic valvuloplasty, Balloon angioplasty of coarctation, PDA closure in preterm neonates | Procedure or surgery | Neonates with congenital heart disease |
Primary outcome
procedure related complications
Time frame: 1 day
complications that may occur during or after procedure
1 secondary outcome
Postprocedure NICU admission
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Safaa H Ali, professor contact
Somaia S Mahmoud, Master principal investigator
Faculty of Medicine, Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcatheter cardiac intervention in people with Transcatheter Neonatal Cardiac Interventions, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Somaia S Mahmoud, Master (201019052097, somaia_sabry922@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
procedure related complications (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.