International Experience in Timing And Choices for Ductal Closure in Patent Ductus Arteriosus:INTERPDA Trial
NCT ID: NCT02910609
Last Updated: 2016-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2017-01-31
2018-03-31
Brief Summary
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Detailed Description
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In recent years, the use of antenatal steroids, postnatal surfactant, noninvasive ventilation strategies and low oxygen saturation targets have affected the incidence of hemodynamically significant PDA (HSPDA). There is not any consensus about the best approach on the clinical management of PDA in preterm infants. Over past years, the management of HSPDA shifted to aggressive medical and surgical intervention from conservative treatment, but conservative treatment approach has been mainly concerned again nowadays.
Today, the three options for the treatment of PDA in preterm infants are conservative approach, pharmacological intervention and surgical ligation. There is not any randomized-controlled trial that demonstrates the superiority of these approaches in preterm infants. Many countries including developed countries only give recommendations, instead of publishing guidelines, on screening, timing of treatment and treatment choices of PDA, because of the differences on management of PDA between the centers even within a single center.
Timing of PDA treatment and treatment choices at preterm infants born before 28 gestation weeks' differ in our country also in many countries over the world. In this study, it is aimed to record the managements of PDA detected beyond postnatal 3 days, to compare the effects of the managements at postnatal 3-7 days and after 7 days on closure, surgical ligation rates and side effects of drugs.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Management at PN 3-7 days
Preterm infants with hemodynamically significant PDA confirmed by echocardiography and are treated at 3-7 days of their life
Echocardiography
Echocardiography is a kind of ultrasound test that shows the inner structure and functions of the heart in both groups.
Management after PN 7 days
Preterm infants with hemodynamically significant PDA confirmed by echocardiography and are treated beyond 7 days of their life
Echocardiography
Echocardiography is a kind of ultrasound test that shows the inner structure and functions of the heart in both groups.
Interventions
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Echocardiography
Echocardiography is a kind of ultrasound test that shows the inner structure and functions of the heart in both groups.
Eligibility Criteria
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Inclusion Criteria
* PDA detected with ductal diameter equal or greater than 1.5 mm and LA/Ao equal or greater than 1.5 on echocardiography at or after postnatal 72 hours of life
Exclusion Criteria
* Infants detected PDA but treated before 72 hours of life
1 Day
28 Days
ALL
No
Sponsors
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Ankara University
OTHER
Responsible Party
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Omer Erdeve
Ankara University, Clinical Profesor
Principal Investigators
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Ömer Erdeve, Professor
Role: PRINCIPAL_INVESTIGATOR
Ankara University
Central Contacts
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Other Identifiers
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Ankara University
Identifier Type: -
Identifier Source: org_study_id
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