[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"patent-ductus-arteriosus-after-premature-birth\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:patent-ductus-arteriosus-after-premature-birth":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100465427","phase-2-co-administration-of-acetaminophen-with-ibuprofen-to-improve-duct-related-outcomes-in-extremely-premature-infants-100465427",false,"NCT05340582","Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants","Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants - The ACEDUCT Trial","Inclusion Criteria:\n\n* Preterm infants born \\\u003C27+0 weeks gestational age\n* Permission given by the attending clinician to approach and then consent obtained from parents\n* Diagnosis of PDA ≥ 1.5 mm on echocardiography with unrestrictive predominantly left to right shunt\n* Designated to receive first treatment course with intravenous or enteral ibuprofen, as decided by the attending team.\n\nExclusion Criteria:\n\n* Chromosomal anomaly\n* Pre-treatment renal dysfunction defined as urine output \\\u003C 1ml\u002Fkg\u002Fhour for the previous 24 hours or serum creatinine \\> 100 micromol\u002FL\n* Pre-treatment hepatic dysfunction defined as serum aminotransferase (ALT) \\> 100 units\u002FL94\n* Platelet count \\\u003C50,000 per microliter\n* Permission denied by the attending clinician to approach parents\n* Parental consent not available\n* Previous exposure to PDA medical treatment with any drug (prophylactic indomethacin use for prevention of intraventricular hemorrhage will not be considered as PDA treatment).","ALL","27 Weeks",{"count":19,"type":20},310,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","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, \\\u003C 27+0 weeks). Ibuprofen and acetaminophen, which act by reducing prostaglandin synthesis, are the most commonly used first and second line agents for PDA treatment across Canada. However, initial treatment failure with monotherapy is a major problem, occurring in \\>60% ELGANs. Treatment failure is associated with worsening rates of mortality and bronchopulmonary dysplasia (BPD), while early treatment success can achieve rates comparable to neonates without PDA. Treatment failure resulting in prolonged disease exposure is thought to be a major contributor. Recently, combination therapy with acetaminophen and ibuprofen has emerged as a new treatment regime. Acetaminophen exerts anti-prostaglandin effect through a different receptor site than ibuprofen, providing a biological rationale for their synergistic action.\n\nThe objective of this study is to evaluate the clinical impact, efficacy and safety of combination regime (Ibuprofen + IV Acetaminophen) for the first treatment course for PDA in ELGANs vs. Ibuprofen alone (current standard treatment).\n\nThe study will also evaluate the effects of combination regime vs. ibuprofen alone on neurodevelopmental outcomes at 18-30 months corrected age.",[26],"Patent Ductus Arteriosus After Premature Birth",[28,29,30,31,32],"Preterm Neonates","Patent Ductus Arteriosus","Echocardiography","Acetaminophen","Ibuprofen","RECRUITING","2026-03-31",{"date":36,"type":37},"2026-04-06","ACTUAL",{"date":39,"type":37},"2022-12-12",{"date":41,"type":20},"2027-04",{"name":43,"class":44},"Mount Sinai Hospital, Canada","OTHER",9,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":45},"100440119","phase-3-selective-early-medical-treatment-of-patent-ductus-arteriosus-in-extremely-low-gestational-age-infants-a-pilot-rct-100440119","NCT05011149","Selective Early Medical Treatment of Patent Ductus Arteriosus in Extremely Low Gestational Age Infants: A Pilot RCT","Selective Early Medical Treatment of the Patent Ductus Arteriosus in Extremely Low Gestational Age Infants: A Pilot Randomized Controlled Trial","SMART-PDA","Inclusion Criteria:\n\n* Preterm infants less than 26 completed weeks (i.e., up to and including 25 weeks and 6 days) of gestation\n\nExclusion Criteria:\n\n* no PDA on initial screening echocardiography\n* congenital heart disease (excluding patent foramen ovale, atrial septal defect or ventricular septal defect with a defect size less than 2mm)\n* other major congenital anomaly\n* decision to withhold\u002Fwithdraw care","72 Hours",{"count":56,"type":20},100,[58],"PHASE3","Background: Among preterm infants, those born at a gestational age less than 26 weeks are considered the most vulnerable with a high risk of short- and long-term health problems that include chronic lung disease, brain bleeds, gut injury, kidney failure and death. Patent ductus arteriosus (PDA) is the most common heart condition with almost 70% preterm infants in this gestational age group being diagnosed with a PDA. Though many PDAs spontaneously resolve on their own, research suggests that if the PDA persists, it may contribute to a number of these short- and long-term health problems. Non-steroidal anti-inflammatory medications such as ibuprofen are commonly used to treat a PDA. Such drugs can also have harmful effects on the gut and kidneys of extremely preterm infants. Therefore, we are unsure if early treatment of a symptomatic PDA in this age group is at all beneficial. Given the wide variation in PDA treatment approaches in this age group, a randomized trial design, where extremely preterm infants with a symptomatic PDA are randomly assigned to early treatment or no early treatment, is essential to address this question.\n\nPurpose of the study: The overall purpose of this pilot study is to assess the feasibility of conducting a large study to explore the following research question: In preterm infants born \\\u003C26 weeks' gestation, is a strategy of selective early medical treatment of a symptomatic PDA better than no treatment at all in the first week of life?\n\nThe main feasibility objectives of this study are:\n\n1. To assess how many eligible infants can be enrolled in the study\n2. To assess how many enrolled infants properly complete the study protocol\n\nImportance: To our knowledge this will be the first study on PDA management in preterm infants that specifically aims to enroll preterm infants born at \\\u003C26 weeks of gestational age who are at the highest risk for PDA-related problems but have been mostly under-represented in previous PDA studies.",[26],[62,63,64],"extremely preterm infant","early medical treatment","randomized controlled trial","2024-06-18",{"date":67,"type":37},"2024-06-21",{"date":69,"type":37},"2022-01-10",{"date":71,"type":20},"2024-09-30",{"name":73,"class":44},"IWK Health Centre"]