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

Patent Ductus Arteriosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02910609
• Other study ID #: Ankara University
• Status: Not yet recruiting
• Phase: N/A
• First received: September 12, 2016
• Last updated: September 20, 2016
• Start date: January 2017
• Est. completion date: March 2018

Study information

• Verified date: September 2016
• Source: Ankara University
• Contact: Ömer Erdeve, Professor
• Phone: +90-505-4812151
• Email: omererdeve[@]yahoo.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: March 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

Intervention

Device:
• Echocardiography
Echocardiography is a kind of ultrasound test that shows the inner structure and functions of the heart in both groups.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spontan closure rate	Rate of patients with spontaneous ductal closure	3 months	Yes
Secondary	Surgical ligation rate	rate of patients who need surgical ligation for hemodynamically significant ductus	3 months	Yes
Secondary	Complications of prematurity		3 months	Yes