Clinical trials: Patent Ductus Arteriosus (PDA)
Patent Ductus Arteriosus
AMPLATZER Duct Occluder II Clinical Study
The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.
- Trial name
- ADO II (NCT00713700)
- Testing
- AMPLATZER Duct Occluder II
- Where
- 25 sites in United States
- Volunteers
- 192 people
- Sponsor
- Abbott Medical Devices
Indomethacin Therapy, Patent Ductus Arteriosus
The Use of B-type Natriuretic Peptide (BNP) to Predict Closure of a Patent Ductus Arteriosus (PDA) in Premature Infants
A patent ductus arteriosus (PDA) is associated with increased morbidity in premature infants. Standard indomethacin treatment is associated with intestinal and renal morbidity.
- Trial name
- NCT00500305
- Testing
- Withhold standard INDO dose if BNP < 100 pg/ml
- Volunteers
- 60 people
- Sponsor
- University of Virginia
Patent Ductus Arteriosus After Premature Birth
Indomethacin PK-PD in Extremely Preterm Neonates
This is a phase II open-label study evaluating the pharmacokinetics and pharmacodynamics of targeted early use of indomethacin for PDA treatment in preterm neonates <27 weeks' gestational age.
- Trial name
- INDO (NCT04025177)
- Testing
- Indomethacin Injection
- Where
- 2 sites in Canada
- Sponsor
- University of Manitoba
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
Nitric Oxide, Endothelin-1, and the Patency of Ductus Arteriosus in Preterm Infants
BACKGROUND Patent ductus arteriosus (PDA) is a frequent clinical event in preterm infant. The cardiopulmonary functions of these preterm babies may be adversely affected by the patency of ductus arteriosus.
- Trial name
- NCT00162903
- Volunteers
- 80 people
- Sponsor
- National Taiwan University Hospital
Preterm, Patent Ductus Arteriosus
NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Circulation Pilot
Non-invasive tools for monitoring of course of disease are important and necessary in the treatment of pre-term/premature infants and sick neonates.
- Conditions
- Preterm, Patent Ductus Arteriosus, Sepsis, Asphyxia
- Trial name
- CE-NeoDoppler (NCT06646250)
- Testing
- NeoDoppler - CE certified
- Where
- Norway
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- St. Olavs Hospital
Bronchopulmonary Dysplasia, Patent Ductus Arteriosus
MISA to NRDS：a Multicenter Study in China
BACKGROUND Treatment of neonatal respiratory distress syndrome with exogenous surfactant and mechanical ventilation made millions of preterm infants survived in neonatal intensive care unit (NICU).
- Conditions
- Bronchopulmonary Dysplasia, Patent Ductus Arteriosus, Intraventricular Hemorrhage, Necrotizing Enterocolitis
- Trial name
- NCT04077333
- Testing
- Minimal Invasive surfactant administration
- Where
- China
- Volunteers
- 237 people
- Sponsor
- Peking University Third Hospital
Patent Ductus Arteriosus, Preterm
Precision Dosing of Oral Ibuprofen for PDA, A Pilot RCT
Newborns born early are at risk for a serious health problem called patent ductus arteriosus (PDA). PDA is a passageway between heart and lung that can cause life-threatening complications such as bleeding in the brain or even…
- Trial name
- MIPD-PDA (NCT07143201)
- Testing
- Standard Dose - Ibuprofen oral suspension, Precision Dose - Ibuprofen oral suspension
- Where
- Canada
- Volunteers
- 26 people
- Sponsor
- Hamilton Health Sciences Corporation
Patent Ductus Arteriosus
Serum Level Measurement of Oral Paracetamol and Oral Ibuprofen for Patent Ductus Arteriosus Treatment in Preterm Infants
The purpose of this study is to determine oral paracetamol and ibuprofen efficacy and safety in relation to serum levels in closure of patent ductus arteriosus in preterm infants.
- Trial name
- NCT01544972
- Testing
- Oral paracetamol, Oral ibuprofen
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
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
Hemodynamically Significant Patent Ductus Arteriosus
Research on the Individualized Treatment Strategy for Extremely Preterm Infants With hsPDA Based on Biomarkers and Targeted Delivery Systems
This project aims to address the need for individualized precision therapy for hemodynamically significant patent ductus arteriosus (hsPDA) in extremely preterm infants by integrating clinical biomarker screening with the design…
- Trial name
- BTDS-IT-hsPDA- (NCT07374146)
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Peking University Third Hospital
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
Heart Disease Congenital, Ventricular Septal Defect
Improving Care for Children With Congenital Heart Disease.
Establish a cardiovascular biomarker profile to help screening for congenital heart disease in infants and children as well as use non-invasive cardiac imaging in combination with such profiling to better predict the need for…
- Conditions
- Heart Disease Congenital, Ventricular Septal Defect, Atrial Septal Defect, Patent Ductus Arteriosus
- Trial name
- NCT04667455
- Testing
- Biomarker analysis at enrolment, Biomarker analyses throughout the study
- Where
- Sweden
- Volunteers
- 313 people, healthy volunteers welcome
- Sponsor
- Lund University Hospital
Patent Ductus Arteriosus
Brain, Gut and Kidney Blood Flow During Medical Closure of PDA
The purpose of this study is to determine how the medications which are used to close the patent ductus arteriosus (PDA) in preterm infants affect brain, kidney and gut blood flow when compared to infants that are not treated…
- Trial name
- NCT00554307
- Testing
- INVOS Cerebral/Somatic oximeter
- Where
- United States
- Sponsor
- University of Louisville
Infant, Premature, Congenital Heart Disease
Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
Patent ductus arteriosus (PDA) is a common problem in the neonatal intensive care unit and can be secondary to prematurity or congenital heart disease (CHD).
- Conditions
- Infant, Premature, Congenital Heart Disease, Patent Ductus Arteriosus, Necrotizing Enterocolitis
- Trial name
- NCT03551600
- Testing
- Near-infrared spectroscopy (NIRS)
- Where
- 3 sites in United States
- Volunteers
- 64 people
- Sponsor
- University of Utah
Patent Ductus Arteriosus
IV Acetaminophen and Patent Ductus Arteriosus
This is a randomized controlled trial to evaluate the efficacy of IV acetaminophen versus IV ibuprofen in closing a hemodynamically significant patent ductus arteriosus in preterm infants.
- Trial name
- NCT03008876
- Testing
- Acetaminophen, Ibuprofen
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Albany Medical College
Premature Infant, Patent Ductus Arteriosus
Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.
The proposed research evaluates tissue oxygenation (StO2) as measured by resonance raman spectroscopy (RRS) in premature infants with and without patent ductus arteriosus (PDA).
- Conditions
- Premature Infant, Patent Ductus Arteriosus, Hemodynamic Instability
- Trial name
- NCT03277768
- Testing
- Resonance Raman Spectroscopy (RRS)
- Where
- 2 sites in United States
- Volunteers
- 55 people
- Sponsor
- University of Florida
PDA, Low; Birthweight, Extremely (999 Grams or Less)
The Efficacy of Implementing a Treatment Algorithm in Managing Patent Ductus Arteriosus (PDA) in the Extremely Low Birth Weight Neonatal Population.
To evaluate whether utilizing a standardized patent ductus arteriosus (PDA) treatment algorithm in managing ELBW (extremely low birth weight) neonates ≤1000 grams (g) improves clinical outcomes and helps prevent undesirable side…
- Trial name
- NCT04379843
- Where
- 2 sites in United States
- Volunteers
- 208 people, healthy volunteers welcome
- Sponsor
- Pediatrix
Patent Ductus Arteriosus
HeartR™ PDA Occluder Post-Market Follow-Up Study
The HeartR™ PDA Occluder Post-Market Clinical Follow-up (PMCF) Study is a multi-center, retrospective, single-arm study sponsored by Lifetech Scientific (Shenzhen) Co., Ltd., aiming to evaluate the long-term safety and…
- Trial name
- NCT07646704
- Testing
- HeartR™ PDA Occluder
- Where
- Indonesia
- Volunteers
- 140 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Coarctation of the Aorta, Aortic Arch Obstruction
The Arch Watch Study: An Integrated Evaluation of Hemodynamics in Infants With Suspected Coarctation of the Aorta
Unrecognized coarctation of the aorta (CoA) is a life-threatening component of congenital heart disease (CHD) in which narrowing of the aorta causes obstructed blood flow to the lower half of the body; it can occur in isolation…
- Trial name
- NCT05880576
- Testing
- Monitoring using resonance Raman spectroscopy, pulse oximetry, blood pressure, and near-infrared spectroscopy
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital