[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"patent-ductus-arteriosus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:patent-ductus-arteriosus":23},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,37,64,98,133,162],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":26,"startDateStruct":29,"completionDateStruct":31,"leadSponsor":33,"locationsCount":36},"100641895","heartr-pda-occluder-post-market-follow-up-study-100641895",false,"NCT07646704","HeartR™ PDA Occluder Post-Market Follow-Up Study","Inclusion Criteria:\n\n1. Patients with a confirmed diagnosis of Patent Ductus Arteriosus (PDA) and were implanted with the HeartR™ PDA Occluder as per IFU instructions\n2. Age ≥ 6 months at the time of implantation.\n3. Weighing ≥ 6 kg at the time of implantation.\n4. Narrowest portion of the PDA ≥ 2mm at the time of implantation.\n\nExclusion Criteria:\n\nPatients did not conduct any follow up visit after hospital discharge.","ALL","6 Months",{"count":18,"type":19},140,"ESTIMATED","OBSERVATIONAL","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 performance of the Lifetech HeartR™ PDA Occluder in real-world clinical practice in Indonesia. A total of 140 subjects diagnosed with Patent Ductus Arteriosus (PDA) and treated with the HeartR™ PDA Occluder according to the Instructions for Use (IFU) will be enrolled.\n\nEligible subjects include patients aged ≥6 months, weighing ≥6 kg, with a PDA narrowest diameter ≥2 mm at the time of implantation. Patients without any follow-up visit after hospital discharge will be excluded from the study.\n\nThe primary endpoint is procedural success at 12 months post-implantation, defined as the absence of major adverse events including stroke\u002FTIA, device embolization, cardiac or vascular perforation, left pulmonary artery stenosis or aortic stenosis requiring re-intervention, and procedure\u002Fdevice-related death, together with complete defect closure confirmed by Doppler echocardiography without residual shunt.\n\nSecondary endpoints include complete closure rates before discharge and at 6 months post-implantation, incidence of left pulmonary artery stenosis or aortic stenosis requiring re-intervention, incidence of device- or procedure-related adverse events (AEs) and serious adverse events (SAEs), as well as all-cause mortality through 24 months post-implantation.",[23],"Patent Ductus Arteriosus","RECRUITING","2026-06-09",{"date":27,"type":28},"2026-06-15","ACTUAL",{"date":30,"type":28},"2025-04-30",{"date":32,"type":19},"2026-12-31",{"name":34,"class":35},"Lifetech Scientific (Shenzhen) Co., Ltd.","INDUSTRY",1,{"id":38,"slug":39,"hasResults":11,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":15,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":49,"conditions":50,"keywords":52,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":36},"100566693","pda-for-kidneys-study-100566693","NCT06658496","PDA for Kidneys Study","Development of a Novel Kidney-focused Approach to Treatment of a Patent Ductus Arteriosus (PDA) in Vulnerable Preterm Neonates - A Pilot Study","PDA4K","Inclusion Criteria:\n\n* Delivered at \\\u003C32 weeks' gestation\n* ≤72 hours of age\n* Inpatient at Meriter Hospital, Inc. NICU\n* At least one parent\u002Fguardian is able to provide parental permission in English or Spanish\n\nExclusion Criteria:\n\n* Major congenital anomalies of kidney\n* Attending physician's discretion to not place NIRS sensors due to clinical concerns\n* In the PI or Co-I's medical opinion, there is a significant likelihood that the neonate would not survive the first 3 days of life\n* Birth parent aged \\\u003C18","1 Minute","7 Days",{"count":48,"type":19},45,"The goal of this observational study is to gather more information on kidney oxygen levels in babies with a patent ductus arteriosus (PDA), and evaluate the relationships between kidney oxygen levels, PDA status and kidney injury.\n\nResearchers will do this by looking at ultrasound images of the heart, analyzing substances in the urine, and evaluating oxygen levels in the kidneys.",[23,51],"Congenital Heart Disease",[53],"neonate","2026-05-12",{"date":56,"type":28},"2026-05-15",{"date":58,"type":28},"2024-12-19",{"date":60,"type":19},"2027-05",{"name":62,"class":63},"University of Wisconsin, Madison","OTHER",{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":15,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":77,"conditions":78,"keywords":84,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":36},"100565751","neodoppler-new-ultrasound-technology-for-continuous-monitoring-of-cerebral-circulation-pilot-100565751","NCT06646250","NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Circulation Pilot","NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Blood Flow in Infants","CE-NeoDoppler","Inclusion Criteria:\n\n* Open fontanelle\n* Healthy preterm or term born neonates\n* Neonates with a medical condition of interest according to the different cohort studies: patent ductus arteriosus, perinatal asphyxia, stroke, pulmonary hypertension, congenital heart condition or infection\u002Fsepsis\u002Fmeningitis\n* Neonates in need of procedures\n\nExclusion Criteria:\n\n* Caregivers not understanding\u002Fspeaking Norwegian or English\n* Caregivers not giving their consent",true,"0 Minutes","12 Months",{"count":76,"type":19},180,"Non-invasive tools for monitoring of course of disease are important and necessary in the treatment of pre-term\u002Fpremature infants and sick neonates. For many years, the ultrasound group in Trondheim has been at the forefront in the development of new ultrasound technology for the diagnosis and monitoring of disease. Several methods previously developed in this research group are today widely used in hospitals around the world. In this project the investigators aim to test a new ultrasound technology that allows continuous monitoring of cerebral blood flow in sick neonates and pre-term children. This technology was CE-certified in October 2022, and in this project the investigators will test the CE-certified version with the newest available approved software.",[79,23,80,81,82,83,51],"Preterm","Sepsis","Asphyxia","Stroke","Pulmonary Hypertension",[85,86,87,88],"Cerebral Doppler","Monitoring","Continuous","Neonate","2026-04-22",{"date":91,"type":28},"2026-04-23",{"date":93,"type":28},"2024-10-20",{"date":95,"type":19},"2029-12-31",{"name":97,"class":63},"St. Olavs Hospital",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":105,"targetDuration":107,"studyType":20,"phases":4,"briefSummary":108,"conditions":109,"keywords":110,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100459602","post-marketing-clinical-follow-up-study-to-evaluate-efficacy-and-safety-of-the-occlutech-pda-occluder-in-patients-with-patent-ductus-arteriosus-defects-100459602","NCT05264753","Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects","A Multicenter, International, Prospective, Retrospective, Post Marketing Clinical Follow Up Study to Evaluate the Efficacy and Safety of the Occlutech Patent Ductus Arteriosus Occluder (PDA Occluder) in Patients With Patent Ductus Arteriosus Defects","Inclusion Criteria:\n\n* A subject of any age will be eligible for PDA closure if he or she meets the indication and area of application as laid down in the IFU. Including subjects more than 3 kg. Thus, the Occlutech PDA Occluder is intended for the non-surgical occlusion of Patent Ductus Arteriosus (PDA) defects.\n* Male or female subjects.\n* Subjects or their parents\u002Fguardians understanding the nature of the study and providing their informed consent to participation.\n* Subjects willing and able to attend the follow-up visits and procedures foreseen by study CIP.\n\nExclusion Criteria:\n\nContraindications as laid down in the IFU:\n\n* Silent ductus or serious pulmonary hypertension:\n* Pulmonary Vascular Resistance (PVR) \\> 8 Wood Units\n* Presence of a known coagulation disorder\n* Thrombus at the position allocated for the implantation\n* A vein thrombosis in the blood vessels chosen for the introducing system\n* An active infection (active endocarditis or other infections causing bacteremia) or history of endocarditis within 3 months from the procedure.\n* Nitinol intolerance (nickel or titanium)\n* Contrast medium intolerance\n* Subjects who have a vascular system (which is used to access the defect) that is too small to admit the required sheath",{"count":106,"type":19},255,"3 Years","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 with patent ductus arteriosus (PDA) defects. Safety and efficacy assessments include vital signs, electrocardiograms, and echocardiographic evaluations performed at baseline\u002Fimplantation (including assessments within 36 hours post procedure), as well as at follow up visits occurring between Day 30 and Day 90, 6 months to 1 year, 1 to 2 years, and 2 to 3 years after implantation.",[23],[111,112,113,114,115,116,117,118,119,120,121,122],"Occlutech PDA Occluder","Patent ductus arteriosus closure","Transcatheter PDA occlusion","Percutaneous catheter-based intervention","Occluder device","Post-marketing clinical follow-up","PMCF","Prospective and retrospective study","Multicenter international study","Efficacy and safety","Echocardiography follow-up","Pediatric cardiology","2026-01-24",{"date":125,"type":28},"2026-01-27",{"date":127,"type":28},"2021-12-20",{"date":129,"type":19},"2029-11-25",{"name":131,"class":35},"Occlutech International AB",15,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":149,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":36},"100603952","phase-2-precision-dosing-of-oral-ibuprofen-for-pda-a-pilot-rct-100603952","NCT07143201","Precision Dosing of Oral Ibuprofen for PDA, A Pilot RCT","Model Informed Precision Dosing of Oral Ibuprofen for Treatment of Persistent Patent Ductus Arteriosus: A Pilot Randomized Controlled Feasibility Trial","MIPD-PDA","Inclusion Criteria:\n\n* Neonates with a gestational age of ≤27+6 weeks\n* Admitted to the neonatal intensive care unit (NICU) at McMaster Children's Hospital (MCH)\n* Diagnosed with PDA in need of treatment based on targeted neonatal echocardiography (TnEcho) performed prior to 27+6 CGA or postnatal age of 3 days, whichever comes later.\n* Obtained parental consent.\n\nExclusion Criteria:\n\n* Major congenital or genetic abnormalities\n* Evidence for clinical or biochemical hepatic or renal failure (AST \\> 225 U\u002FL, ALT \\> 150 U\u002FL, or serum creatinine \\> 130 µmol\u002FL)\n* Sepsis - as defined by confirmed uncontrolled\u002Factive sepsis which will preclude any treatment of PDA\n* Contraindications to receive oral ibuprofen:\n* Severe hyperbilirubinemia in need for exchange transfusion\n* Severe feeding intolerance\n* Necrotizing enterocolitis (NEC)\n* Gastrointestinal perforation\n* Active bleeding\n* Severe thrombocytopenia (\\\u003C 50× 109\u002FL)","28 Weeks",{"count":143,"type":19},26,"INTERVENTIONAL",[146],"PHASE2","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 death if it remains open and large. When closure of PDA is needed, doctors make every attempt to do it as soon as possible. Ibuprofen is the best drug to close the PDA, but it only works for 50% of small newborns. The investigators have shown before that small newborns handle ibuprofen differently and the amount of active ibuprofen that reaches their blood can be very unpredictable. Studies have shown if enough ibuprofen reaches the body, it can close the PDA. Therefore the investigators designed this study to see whether it is possible to give each newborn the right amount of ibuprofen that their body needs to close the PDA. The investigators will compare two ways to give ibuprofen in a small number of newborns: 1 - standard amount of ibuprofen to everyone, which is the usual care or 2 - ibuprofen doses that will be changed based on how much active ibuprofen has reached the body and how well the newborn's PDA is closing. The investigators will then compare the number of PDAs closed in each group and closely monitor any possible challenges for this new practice. By doing this project, the goals can be summarized as below:\n\nA. Primary goal: To determine if it is feasible to successfully run a larger study in the future.\n\nB. Secondary goals\n\n1. To assess how well and how safely the personalized (MIPD) method works, using a tool called WAPPS-PDA to guide dosing.\n2. To compare the effectiveness and safety of the personalized method with standard ibuprofen dosing.\n3. To identify drug levels in the blood (Cmin, AUC0-24, AUC0-72) that are associated with complete, partial, or no response to treatment.",[23,79],[139,150,151,152],"PDA","Precision Dosing","Ibuprofen","2025-08-19",{"date":155,"type":28},"2025-08-27",{"date":157,"type":28},"2024-07-04",{"date":159,"type":19},"2027-07",{"name":161,"class":63},"Hamilton Health Sciences Corporation",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":172,"conditions":173,"keywords":178,"overallStatus":180,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":185,"leadSponsor":187,"locationsCount":4},"100519559","pufas-in-preterm-infants-100519559","NCT06045130","PUFAs in Preterm Infants","Characteristics of PUFAs Composition in Preterm Infants and Its Impact on Disease Prognosis","PIPI","Inclusion Criteria:\n\nInfants born between 24 and 36 weeks of gestational age who are admitted within 24 hours of birth, including both premature and full-term newborns.\n\n\\-\n\nExclusion Criteria:\n\nInfants with severe congenital developmental abnormalities, those requiring external supplementation of PUFAs in addition to standard intravenous nutrition and breastfeeding, and those with a severe prognosis indicating non-survival during their hospitalization.\n\n\\-",{"count":171,"type":19},600,"The research endeavors to examine the critical composition of Polyunsaturated Fatty Acids (PUFAs) in premature infants across different gestational stages and under varying disease conditions, and delineate the metabolic attributes of PUFAs in premature infants and their interplay with the onset of diseases. This study anticipates furnishing a theoretical foundation for the rationalization of PUFAs supplementation in premature infants and for informing strategies related to disease prevention and management.",[174,175,176,80,177,23],"Necrotizing Enterocolitis","Intraventricular Hemorrhage","BPD - Bronchopulmonary Dysplasia","Periventricular Leukomalacia",[179],"PUFAs","NOT_YET_RECRUITING","2023-09-13",{"date":183,"type":28},"2023-09-21",{"date":183,"type":19},{"date":186,"type":19},"2026-08-31",{"name":188,"class":63},"The First Hospital of Jilin University"]