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

• Conditions: Patent Ductus Arteriosus
• Interventions: Device: Echocardiography

• Registration Number: NCT02910609
• Lead Sponsor: Ankara University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2016-09
• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-09-20
• Last Update Submitted: 2016-09-20
• Study First Posted: 2016-09-22
• Last Update Posted: 2016-09-22
• Study Start: 2017-01
• Primary Completion: 2018-01
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Management at PN 3-7 days	Echocardiography	Preterm infants with hemodynamically significant PDA confirmed by echocardiography and are treated at 3-7 days of their life
Management after PN 7 days	Echocardiography	Preterm infants with hemodynamically significant PDA confirmed by echocardiography and are treated beyond 7 days of their life

Primary Outcome Measures

Name	Time	Method
Spontan closure rate	3 months	Rate of patients with spontaneous ductal closure

Secondary Outcome Measures

Name	Time	Method
Surgical ligation rate	3 months	rate of patients who need surgical ligation for hemodynamically significant ductus
Complications of prematurity	3 months