Early Treatment Versus Expectant Management of PDA in Preterm Infants

Status Completed

Clinical Trial Summary

Patent ductus arteriosus (PDA) in very preterm newborns is associated with severe neonatal mor-bidity: intraventricular hemorrhage (IVH), bronchopulmonary dysplasia (BPD), necrotizing en-terocolitis (NEC), retinopathy of prematurity (ROP). Existing methods of management PDA do not reduce the incidence of these diseases. The efficacy of cyclooxygenase inhibitors (COX) which are currently the standard of treatment in extreme preterm infants is about 70-80%. COX inhibitors have significant side effects. On the other hand, surgical ligation of the ductus arteriosus is associated with deterioration due to cardio-pulmonary problems and long-term complications. Paracetamol has been proposed for treatment of hemodynamically significant PDA because it has a different mecha-nism of action compared with COX inhibitors and a better safety profile. Recently, expectant approach has becoming more popular, although there is not enough evidence to support it. The objective of this study is to investigate whether in preterm infants, born at a GA less than 32 weeks, with a PDA (diameter > 1.5 mm) at a postnatal age of < 72 h, an expectant management is non-inferior to early treatment with regard to the composite of mortality and/or severe morbidity.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03860428
Study type	Interventional
Source	Lviv National Medical University
Contact
Status	Completed
Phase	N/A
Start date	February 15, 2019
Completion date	July 20, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04986839` - PAIR (Paracetamol and Ibuprofen Research) Pilot Trial	Phase 2/Phase 3
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	`NCT02621528` - Lifetech CeraFlex™ Post-Market Surveillance Study	N/A
Completed	`NCT03551600` - Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
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.