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Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants — PIVOTAL  

Ductus Arteriosus, Patent Clinical Trial

Official title:
Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants

Clinical Trial Summary

Patent Ductus Arteriosus is a developmental condition commonly observed among preterm infants. It is a condition where the opening between the two major blood vessels leading from the heart fail to close after birth. In the womb, the opening (ductus arteriosus) is the normal part of the circulatory system of the baby, but is expected to close at full term birth. If the opening is tiny, the condition can be self-limiting. If not, medications/surgery are options for treatment. There are two ways to treat patent ductus arteriosus - one is through closure of the opening with an FDA approved device called PICCOLO, the other is through supportive management (medications). No randomized controlled trials have been done previously to see if one of better than the other. Through our PIVOTAL study, the investigators aim to determine is one is indeed better than the other - if it is found that the percutaneous closure with PICCOLO is better, then it would immediately lead to a new standard of care. If not, then the investigators avoid an invasive costly procedure going forward.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05547165
Study type Interventional
Source Nationwide Children's Hospital
Contact Carl H Backes
Phone 16143556729
Email carl.backes@nationwidechildrens.org
Status Recruiting
Phase N/A
Start date February 21, 2023
Completion date February 28, 2026
View Details
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Completed NCT00799123 - Urine NT-proBNP Levels and Echocardiographic Findings in Very Low Birth Weight (VLBW) Infants N/A
Completed NCT00528736 - Plasma B-Type Natriuretic Peptide Concentrations in Preterm Infants < 28 Weeks N/A
Completed NCT02002741 - Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants Phase 2/Phase 3