PDA Stent in Neonates With PDA Dependent Pulmonary Circulation

Not Applicable

Recruiting

• Conditions: Neonatal Cyanosis Due to PDA Dependent Pulmonary Circulation
• Interventions: Device: Catheter-guided PDA stent implantation

• Registration Number: NCT05857293
• Lead Sponsor: Sohag University

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-04-01
• Status Verified: 2023-05
• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-10
• Last Update Submitted: 2023-05-10
• Study First Posted: 2023-05-12
• Last Update Posted: 2023-05-12
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Neonates and young infants with duct dependent pulmonary circulation

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Exclusion Criteria

• Untreated sepsis.
• Coagulopathy.
• PDA dependent systemic circulation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cyanotic neonate	Catheter-guided PDA stent implantation	Cyanotic neonates with PDA dependent pulmonary circulation will be treated with catheter guided PDA stent implantation to keep duct patency and improve oxygen saturation

Primary Outcome Measures

Name	Time	Method
Change in Oxygen saturation	Change in oxygen saturation within 24 hours	Using pulse oximeter to assess oxygen saturation
Evaluation of duct patency	1 month	Using echocardiography assess flow through the duct

Trial Locations

Locations (1)

Sohag University; 🇪🇬 Sohag, Egypt