Back to resultsPDA Stent in Neonates With PDA Dependent Pulmonary Circulation
Primary Purpose
Neonatal Cyanosis Due to PDA Dependent Pulmonary Circulation
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Catheter-guided PDA stent implantation
Sponsored by
About this trial
This is an interventional treatment trial for Neonatal Cyanosis Due to PDA Dependent Pulmonary Circulation
Eligibility Criteria
Inclusion Criteria: Neonates and young infants with duct dependent pulmonary circulation Exclusion Criteria: Untreated sepsis. Coagulopathy. PDA dependent systemic circulation.
Sites / Locations
- Sohag UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cyanotic neonate
Arm Description
Cyanotic neonates with PDA dependent pulmonary circulation will be treated with catheter guided PDA stent implantation to keep duct patency and improve oxygen saturation
Outcomes
Primary Outcome Measures
Change in Oxygen saturation
Using pulse oximeter to assess oxygen saturation
Evaluation of duct patency
Using echocardiography assess flow through the duct
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05857293
Brief Title
PDA Stent in Neonates With PDA Dependent Pulmonary Circulation
Official Title
Outcomes for Patent Ductus Arteriosus Stenting in Neonates With Duct-Dependent Pulmonary Circulation: A Prospective Study at Sohag University Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Cyanosis Due to PDA Dependent Pulmonary Circulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cyanotic neonate
Arm Type
Experimental
Arm Description
Cyanotic neonates with PDA dependent pulmonary circulation will be treated with catheter guided PDA stent implantation to keep duct patency and improve oxygen saturation
Intervention Type
Device
Intervention Name(s)
Catheter-guided PDA stent implantation
Other Intervention Name(s)
PDA stent
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Oxygen saturation
Description
Using pulse oximeter to assess oxygen saturation
Time Frame
Change in oxygen saturation within 24 hours
Title
Evaluation of duct patency
Description
Using echocardiography assess flow through the duct
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Neonates and young infants with duct dependent pulmonary circulation
Exclusion Criteria:
Untreated sepsis.
Coagulopathy.
PDA dependent systemic circulation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Somaia S Mahmoud, Master
Phone
201019052097
Email
somaia_sabry922@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Somaia S Mahmoud, Master
Organizational Affiliation
Sohag University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sohag University
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Somaia S Mahmoud, Master
Phone
201019052097
Email
somaia_sabry922@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
PDA Stent in Neonates With PDA Dependent Pulmonary Circulation
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