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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational [Patient Registry]

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

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 Summary:

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.


Sponsor: Ankara University

Current Primary Outcome: Spontan closure rate [ Time Frame: 3 months ]

Rate of patients with spontaneous ductal closure


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Surgical ligation rate [ Time Frame: 3 months ]
    rate of patients who need surgical ligation for hemodynamically significant ductus
  • Complications of prematurity [ Time Frame: 3 months ]


Original Secondary Outcome: Same as current

Information By: Ankara University

Dates:
Date Received: September 12, 2016
Date Started: January 2017
Date Completion: March 2018
Last Updated: September 20, 2016
Last Verified: September 2016