International Experience in Timing And Choices for Ductal Closure in Patent Ductus Arteriosus:INTERPDA Trial

Study Overview
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Brief Summary
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The three options for the treatment of patent ductus arterioles (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.

Detailed Description
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Patent ductus arteriosus (PDA), of which incidence is inversely related to gestational age and birth weight, is one of the the most common conditions among preterm infants. 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.

Official Title
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International Experience in Timing And Choices of Treatment For Ductal Closure in Patent Ductus Arteriosus: INTERPDA Trial

Conditions
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Patent Ductus Arteriosus

Intervention / Treatment
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* Device: Echocardiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants born at 24 0/7-28 6/7 gestation weeks' 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 died before 72 hours of life Infants detected PDA but treated before 72 hours of life

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Management at PN 3-7 days<br>Preterm infants with hemodynamically significant PDA confirmed by echocardiography and are treated at 3-7 days of their life | Device: Echocardiography<br>* Echocardiography is a kind of ultrasound test that shows the inner structure and functions of the heart in both groups.<br>|
| Management after PN 7 days<br>Preterm infants with hemodynamically significant PDA confirmed by echocardiography and are treated beyond 7 days of their life | Device: Echocardiography<br>* Echocardiography is a kind of ultrasound test that shows the inner structure and functions of the heart in both groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontan closure rate | Rate of patients with spontaneous ductal closure | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical ligation rate | rate of patients who need surgical ligation for hemodynamically significant ductus | 3 months | 
| Complications of prematurity |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm, patent ductus arterioles, treatment