International Experience in Timing And Choices for Ductal Closure in

Status Not yet recruiting

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.

Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02910609
Study type	Observational [Patient Registry]
Source	Ankara University
Contact	Ömer Erdeve, Professor
Phone	+90-505-4812151
Email	omererdeve@yahoo.com
Status	Not yet recruiting
Phase	N/A
Start date	January 2017
Completion date	March 2018

View Details

See also
Status	Clinical Trial	Phase
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Recruiting	`NCT03648437` - Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus	Phase 1
Completed	`NCT04126512` - Timing of Surgical PDA Ligation and Neonatal Outcomes
Not yet recruiting	`NCT06045130` - PUFAs in Preterm Infants
Completed	`NCT00217191` - Ibuprofen and Renal Function in Premature Infants	Phase 4
Not yet recruiting	`NCT02894970` - A New Device for Measuring of Lung Photoplethysmography and Pulmonic Arterial Saturation	N/A
Completed	`NCT03551600` - Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
Completed	`NCT02621528` - Lifetech CeraFlex™ Post-Market Surveillance Study	N/A
Terminated	`NCT03982342` - Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants	N/A
Completed	`NCT01479218` - Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus	N/A
Completed	`NCT00795990` - Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants	N/A
Terminated	`NCT00802685` - Timing of PDA Closure and Respiratory Outcome in Premature Infants	N/A
Withdrawn	`NCT00554307` - Brain, Gut and Kidney Blood Flow During Medical Closure of PDA	N/A
Completed	`NCT03723889` - Patent Ductus Arteriosus and Splanchnic Oxygenation at First Feed
Recruiting	`NCT04397913` - Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA
Completed	`NCT02750228` - PDA Post NICU Discharge
Recruiting	`NCT02220270` - Hyperion™ International Registry Trial	N/A
Completed	`NCT01593163` - Echocardiographically Guided Versus Standard Ibuprofen Treatment for Patent Ductus Arteriosus	Phase 3
Recruiting	`NCT06298344` - The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease	Early Phase 1
Completed	`NCT03277768` - Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms