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

NCT02910609 | Unknown DMC

• 1 other identifier: Ankara University
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Patent Ductus Arteriosus

Keywords

preterm; patent ductus arterioles; treatment

Outcome Measures

Primary Outcomes (1)

• Spontan closure rate

  Rate of patients with spontaneous ductal closure

  3 months

Secondary Outcomes (2)

• Surgical ligation rate

  3 months

• Complications of prematurity

  3 months

Study Arms (2)

Management at PN 3-7 days

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

Device: Echocardiography

Management after PN 7 days

Preterm infants with hemodynamically significant PDA confirmed by echocardiography and are treated beyond 7 days of their life

Device: Echocardiography

Interventions

Echocardiography DEVICE

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

Management after PN 7 days; Management at PN 3-7 days

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants born at 24 0/7-28 6/7 gestation weeks' who were performed echocardiography at or after postnatal 72 hours of life, and detected ductal diameter equal or greater than 1.5 mm and LA/Ao equal or greater than 1.5 are the candidates for the study. The management of PDA and the other data of these infants will be registered to online registry system.

You may qualify if:

• 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

You may not qualify if:

• Infants died before 72 hours of life
• Infants detected PDA but treated before 72 hours of life

Sponsors & Collaborators

• Ankara University: lead

MeSH Terms

Conditions

Ductus Arteriosus, Patent; Premature Birth

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Ömer Erdeve, Professor

  Ankara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ömer Erdeve, Professor

CONTACT

+90-505-4812151; omererdeve@yahoo.com

Emel Okulu, Attending

CONTACT

+90-505-2530974; emelokulu@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ankara University, Clinical Profesor

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 22, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: March 1, 2018
• Last Updated: September 22, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share