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

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Brief Title

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

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 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 Type

Observational [Patient Registry]


Primary Outcome

Spontan closure rate

Secondary Outcome

 Surgical ligation rate

Condition

Patent Ductus Arteriosus

Intervention

Echocardiography

Study Arms / Comparison Groups

 Management at PN 3-7 days
Description:  Preterm infants with hemodynamically significant PDA confirmed by echocardiography and are treated at 3-7 days of their life

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

1000

Start Date

January 2017

Completion Date

March 2018

Primary Completion Date

January 2018

Eligibility Criteria

        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
      

Gender

All

Ages

N/A - 28 Days

Accepts Healthy Volunteers

No

Contacts

Ömer Erdeve, Professor, +90-505-4812151, [email protected]



Administrative Informations


NCT ID

NCT02910609

Organization ID

Ankara University


Responsible Party

Principal Investigator

Study Sponsor

Ankara University


Study Sponsor

Ömer Erdeve, Professor, Principal Investigator, Ankara University


Verification Date

September 2016