Neonatal Cyanosis Due to PDA Dependent Pulmonary CirculationNCT05857293
PDA Stent in Neonates With PDA Dependent Pulmonary Circulation
A study testing Catheter-guided PDA stent implantation in people with Neonatal Cyanosis Due to PDA Dependent Pulmonary Circulation, run by Sohag University at 1 site in Egypt.
Trial summary
After echocardiography confirmation of PDA dependent pulmonary circulation in cyanotic neonates, catheter-guided PDA stent implantation will be done. Under general Anasthesia and after discontinuation of prostaglandin 4-6 hours before procedure, obtain vascular access and unfractionated heparin is given, then duct is… Read more about this study
- Who is it for?
- Ages 1 hour to 2 months
- Conditions the study is for
- Neonatal Cyanosis Due to PDA Dependent Pulmonary Circulation
- What is being tested?
- Catheter-guided PDA stent implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 31 Mar 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 2 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates and young infants with duct dependent pulmonary circulation
Who cannot join
- Untreated sepsis.
- Coagulopathy.
- PDA dependent systemic circulation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag
Somaia S Mahmoud, Master, 201019052097, somaia_sabry922@yahoo.com
About this study
Official title: Outcomes for Patent Ductus Arteriosus Stenting in Neonates With Duct-Dependent Pulmonary Circulation: A Prospective Study at Sohag University Hospital
After echocardiography confirmation of PDA dependent pulmonary circulation in cyanotic neonates, catheter-guided PDA stent implantation will be done. Under general Anasthesia and after discontinuation of prostaglandin 4-6 hours before procedure, obtain vascular access and unfractionated heparin is given, then duct is accessed via a cut pig-tail or Judkins right [JR] catheter, and is crossed by PTCA wire to be carefully placed in the left or right branch pulmonary arteries, choose proper stent diameter and length, place the stent and confirm it's position, NICU admission for the neonate with heparin infusion for 24-48 hrs and acetylsalicylic acid is given then follow up the patient by pulse oximeter and echocardiography
- Being tested
- Catheter-guided PDA stent implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter-guided PDA stent implantationDevice
Also called PDA stent
PDA stent is the primary treatment for patients with duct-dependent pulmonary circulation. It serves as a temporary bridge for later surgical repair by keeping the duct patent to improve oxygen saturation
| Study group | Role | What they receive |
|---|---|---|
| Cyanotic neonate | Experimental | Cyanotic neonates with PDA dependent pulmonary circulation will be treated with catheter guided PDA stent implantation to keep duct patency and improve oxygen saturation Receives: Device: Catheter-guided PDA stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oxygen saturation
Using pulse oximeter to assess oxygen saturation
Measured: Change in oxygen saturation within 24 hours
Evaluation of duct patency
Using echocardiography assess flow through the duct
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 Apr 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Cyanosis Due to PDA Dependent Pulmonary CirculationStudies of the same condition, open and under way.
- 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
- 20 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, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857293
- Sponsor's protocol ID
- Soh-Med-23-04-03MD
- Status last verified
- May 2023
- First submitted
- 2 May 2023
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes for Patent Ductus Arteriosus Stenting in Neonates With Duct-Dependent Pulmonary Circulation: A Prospective Study at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05857293
- Acronym / sponsor ID
- Soh-Med-23-04-03MD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 12 May 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.
After echocardiography confirmation of PDA dependent pulmonary circulation in cyanotic neonates, catheter-guided PDA stent implantation will be done. Under general Anasthesia and after discontinuation of prostaglandin 4-6 hours before procedure, obtain vascular access and unfractionated heparin is given, then duct is accessed via a cut pig-tail or Judkins right [JR] catheter, and is crossed by PTCA wire to be carefully placed in the left or right branch pulmonary arteries, choose proper stent diameter and length, place the stent and confirm it's position, NICU admission for the neonate with heparin infusion for 24-48 hrs and acetylsalicylic acid is given then follow up the patient by pulse oximeter and echocardiography
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyanotic neonate | Experimental | Device: Catheter-guided PDA stent implantationCyanotic neonates with PDA dependent pulmonary circulation will be treated with catheter guided PDA stent implantation to keep duct patency and improve oxygen saturation |
Who may qualify
- Ages
- 1 hour to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Neonates and young infants with duct dependent pulmonary circulation
Key exclusion criteria (3 listed)
- Untreated sepsis.
- Coagulopathy.
- PDA dependent systemic circulation.
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 |
|---|---|---|
| Catheter-guided PDA stent implantationAlso: PDA stentPDA stent is the primary treatment for patients with duct-dependent pulmonary circulation. It serves as a temporary bridge for later surgical repair by keeping the duct patent to improve oxygen saturation | Device | Cyanotic neonate |
Primary outcome
Change in Oxygen saturation
Time frame: Change in oxygen saturation within 24 hours
Using pulse oximeter to assess oxygen saturation
Evaluation of duct patency
Time frame: 1 month
Using echocardiography assess flow through the duct
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
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.
Somaia S Mahmoud, Master principal investigator
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 Catheter-guided PDA stent implantation in people with Neonatal Cyanosis Due to PDA Dependent Pulmonary Circulation, 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 3 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 12 May 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?
Change in Oxygen saturation (time frame: Change in oxygen saturation within 24 hours). The study lists 2 primary outcomes in all. 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 12 May 2023.