PDA Stent in Neonates With PDA Dependent Pulmonary Circulation

Sohag University

Status: Enrolling

Conditions: Neonatal Cyanosis Due to PDA Dependent Pulmonary Circulation

Treatments: Device: Catheter-guided PDA stent implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT05857293

Soh-Med-23-04-03MD

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 1 hour to 2 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

Neonates and young infants with duct dependent pulmonary circulation

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Cyanotic neonate

Experimental group

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

Treatment:

Device: Catheter-guided PDA stent implantation