Clinical trials: PDA
Patent Ductus Arteriosus After Premature Birth
PDA Treatment With Ibuprofen and Changes in Tissue Oxygenation.
Babies who are born very prematurely are often born with murmurs in the heart. In preterm babies, one of the most common causes of murmur is the presence of a PDA.
- Trial name
- NCT05325177
- Testing
- Standard Dose Ibuprofen, High Dose Ibuprofen
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- Ottawa Hospital Research Institute
Patent Ductus Arteriosus
Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants
We hypothesize that feeding preterm infants while they receive indomethacin or ibuprofen therapy for treatment of a patent ductus arteriosus will decrease the incidence of feeding intolerance and shorten the time period that…
- Trial name
- NCT00728117
- Testing
- feeding, fasting
- Where
- 14 sites in United States
- Volunteers
- 177 people
- Sponsor
- University of California, San Francisco
Patent Ductus Arteriosus
Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA
The investigator's purpose is to study the population pharmacokinetics of paracatamol and ibuprofen in neonates with patent ductus arteriosus (PDA) and assess the feasibility of dosage individualization.
- Trial name
- NCT04397913
- Testing
- Paracetamol, Ibuprofen
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Shandong University
Patent Ductus Arteriosus
Pocket Echocardiography System (PES) for Detection of PDA in Neonates
This is a single-center, feasibility study involving all neonates admitted to the neonatal intensive care unit with orders for a cardiac echo evaluation. Parents will be approached and provided a description of the study.
- Trial name
- NCT01790750
- Testing
- PES first, then FFES
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Florida
Premature Infants, Patent Ductus Arteriosus
Ibuprofen and Renal Function in Premature Infants
Purpose of the study: 1. To evaluate renal function maturation within the first month of life in very premature infants. 2. To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter renal function…
- Trial name
- NCT00217191
- Testing
- Ibuprofen
- Where
- 3 sites in France
- Volunteers
- 120 people
- Sponsor
- Maternite Regionale Universitaire
Extremely Premature Newborn (Born Before 32 Weeks' Gestation)
Description of Changes in NIRS as a Function of Ductus Arteriosus Status in Very Premature Babies Born Before 32 WG at the DIJON University Hospital
Monitoring patent ductus arteriosus is currently performed using echocardiography, an operator-dependent examination which requires holding the child on their back and which is potentially time-consuming.
- Trial name
- CAPNIRS (NCT06153771)
- Testing
- Collection of brain and kidney NIRS measurements, echocardiography
- Where
- France
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire Dijon
Patent Ductus Arteriosus
Paracetamol Treatment of the Borderline Significant PDA
The therapeutic approach to the patent ductus arteriosus (PDA) in the premature neonate remains controversial. Currently it is generally accepted to treat only hemodynamically significant PDAs.
- Trial name
- NCT02819414
- Testing
- Paracetamol drops
- Where
- Israel
- Volunteers
- 80 people
- Sponsor
- Shaare Zedek Medical Center
Patent Ductus Arteriosus
Early Ibuprofen Treatment of Patent Ductus Arteriosus (PDA) in Premature Infants (TRIOCAPI)
Very premature infants with a large ductus, selected by an early echocardiogram, will receive either ibuprofen or placebo before 12 hours of life.
- Trial name
- TRIOCAPI (NCT01630278)
- Testing
- Ibuprofen
- Where
- 11 sites in France
- Volunteers
- 363 people
- Sponsor
- Nantes University Hospital
Patent Ductus Arteriosus (PDA)
Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder
AGA-004 - The objective of the study is to determine safety, effectiveness and clinical utility of the AMPLATZER Duct Occluder in patients with patent ductus arteriosus.
- Trial name
- NCT00583596
- Testing
- Device closure with AMPLATZER Duct Occluder, Objective Performance Criteria
- Where
- 24 sites in United States
- Volunteers
- 436 people
- Sponsor
- Abbott Medical Devices
Patent Ductus Arteriosus
Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus
The purpose of this pilot trial is to study efficacy and safety of simultaneous intravenous (iv) ibuprofen/indomethacin and paracetamol medications in the closure of patent ductus arteriosus (PDA) in preterm infants.
- Trial name
- PAI (NCT03648437)
- Testing
- Paracetamol 10Mg/mL, 0.45% Sodium Chloride, Ibuprofen
- Where
- 4 sites in Finland
- Volunteers
- 22 people
- Sponsor
- University of Oulu
Patent Ductus Arteriosus
Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects
This retrospective and prospective, multicenter, international post marketing follow up study evaluates the safety and efficacy of the Occlutech® PDA Occluder, delivered using the Occlutech Occlusions Pusher (OOP), in subjects…
- Trial name
- NCT05264753
- Testing
- Occlutech® PDA Occluder
- Where
- 15 sites in Canada, France and 7 more
- Volunteers
- 255 people
- Sponsor
- Occlutech International AB
Congenital Heart Disease in Children
Left Ventricular Dysfunction Post-surgical Patent Ductus Arteriosus Ligation in Children: Predictor Factors Analysis
Background: PDA is viewed as a standout amongst the most widely recognized congenital heart defects in children and its closure is responsible for many hemodynamic changes that require intervention and care.
- Trial name
- NCT04018079
- Volunteers
- 50 people
- Sponsor
- South Valley University
Atrial Septal Defects, Patent Ductus Arteriosus
Hyperion™ International Registry Trial
The purpose of this study is to determine the safety, performance and efficacy of the Hyperion™ Occluder Systems during treatment of ASD and PDA patients.
- Trial name
- COM-01 (NCT02220270)
- Testing
- ASD and PDA closure
- Where
- 10 sites in Algeria, China and 2 more
- Volunteers
- 200 people
- Sponsor
- European Cardiovascular Research Center
Shock, Preterm Birth Complication
Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Randomized Controlled Trial
The goal of this clinical trial is to determine the effectiveness of early use of hydrocortisone (since the diagnosis of shock) for its resolution within the first 72 hours in premature infants under 1,500 g.
- Conditions
- Shock, Preterm Birth Complication, Preterm Intraventricular Hemorrhage, Asphyxia Perinatal
- Trial name
- NCT07248761
- Testing
- Intravascular Hydrocortisone (stress dosage): 1 mg/k/dose each 8 hours for 5 days, Vasoactive drug therapies
- Where
- Mexico
- Volunteers
- 76 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
Patent Ductus Arteriosus
Early Treatment Versus Expectative Management of PDA in Preterm Infants
Much controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants, especially in those born at a gestational age <28 weeks and/or a birth weight ≦1000 grams due to a lack of evidence for…
- Trial name
- BeNeDuctus (NCT02884219)
- Testing
- Ibuprofen, Expectative Management, Indomethacin
- Where
- 13 sites in Belgium, Netherlands
- Volunteers
- 273 people
- Sponsor
- Radboud University Medical Center
Ductus Arteriosus, Patent
NIT-OCCLUD PDA Phase II Sentinel Trial
The purpose of this study is to evaluate the safety and efficacy of the Nit-Occlud -PDA Occlusion System for transcatheter closure of PDA with minimum angiographic diameter less than 4 mm, and to compare one year safety and…
- Trial name
- NCT00828334
- Testing
- Transcatheter PDA Coil
- Where
- 15 sites in United States
- Volunteers
- 357 people
- Sponsor
- PFM Medical, Inc
Congenital Heart Disease, Congenital Heart Disease (CHD)
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Starlight Cardiovascular, Inc. is sponsoring a prospective, multi-center, study to evaluate safety and effectiveness of the Lifeline Ductus Arteriosus Stent System.
- Trial name
- NCT07114718
- Testing
- Ductus Arteriosus Stent
- Where
- 11 sites in United States
- Volunteers
- 45 people
- Sponsor
- Starlight Cardiovascular Inc
Patent Ductus Arteriosus, Infant, Premature
Ibuprofen vs Expectant Management for hsPDA in Preterm Infants: Retrospective Cohort
This retrospective cohort study compares ibuprofen treatment versus expectant management for hemodynamically significant patent ductus arteriosus (hsPDA) in preterm infants.
- Trial name
- IMPACT-PDA (NCT07533721)
- Testing
- Ibuprofen
- Where
- China
- Volunteers
- 541 people
- Sponsor
- Shengjing Hospital
Patent Ductus Arteriosus After Premature Birth
Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants
Patent ductus arteriosus (PDA), the most common cardiovascular complication of prematurity, is associated with higher mortality and morbidities in extremely low gestational age neonates (ELGANs, < 27+0 weeks).
- Trial name
- NCT05340582
- Testing
- Acetaminophen Injection, Ibuprofen 20 mg/mL oral suspension or Ibuprofen lysine 10 mg/mL injection solution (Neoprofen), Sodium chloride 0.9% injection
- Where
- 9 sites in Australia, Canada and 2 more
- Volunteers
- 310 people
- Sponsor
- Mount Sinai Hospital, Canada
Bronchopulmonary Dysplasia
Ascorbyl Peroxide Association With Bronchopulmonary Dysplasia
Urinary ascorbyl peroxide level in the first week of life will be a good predictor of Bronchopulmonary dysplasia (BPD) in preterm infants less than 33 weeks of gestation.
- Trial name
- NCT01439295
- Where
- Canada
- Volunteers
- 51 people
- Sponsor
- St. Justine's Hospital