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PDA Stent in Neonates With PDA Dependent Pulmonary Circulation

NCT05857293 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-05-12

No results posted yet for this study

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

Conditions

  • Neonatal Cyanosis Due to PDA Dependent Pulmonary Circulation

Interventions

DEVICE

Catheter-guided PDA stent implantation

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

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Principal Investigators

  • Somaia S Mahmoud, Master · Sohag University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Hour
Max Age
2 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05857293 on ClinicalTrials.gov