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PDA Stent in Neonates With PDA Dependent Pulmonary Circulation

Outcomes for Patent Ductus Arteriosus Stenting in Neonates With Duct-Dependent Pulmonary Circulation: A Prospective Study at Sohag University Hospital

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05857293
Enrollment
20
Registered
2023-05-12
Start date
2023-04-01
Completion date
2025-03-31
Last updated
2023-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Cyanosis Due to PDA Dependent Pulmonary Circulation

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

Interventions

DEVICECatheter-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

Sohag University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Hours to 2 Months
Healthy volunteers
No

Inclusion criteria

Neonates and young infants with duct dependent pulmonary circulation

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Oxygen saturationChange in oxygen saturation within 24 hoursUsing pulse oximeter to assess oxygen saturation
Evaluation of duct patency1 monthUsing echocardiography assess flow through the duct

Countries

Egypt

Contacts

Primary ContactSomaia S Mahmoud, Master
somaia_sabry922@yahoo.com201019052097

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026