[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100440119":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":38,"responsibleParty":150,"collaborators":153,"id":173,"slug":174,"hasResults":175,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":175,"sex":181,"minAge":18,"maxAge":182,"enrollmentInfo":183,"targetDuration":18,"studyType":186,"phases":187,"briefSummary":189,"conditions":190,"keywords":192,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":205},{"fullName":5,"class":6},"IWK Health Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Selective early medical treatment (SMART) strategy","EXPERIMENTAL","Infants who are randomized to experimental group will follow the SMART treatment protocol, which includes echocardiographic screening every 72 hours to categorize PDA disease severity by combining clinical and echocardiographic features. At any evaluation if patients are found to have a \"severe PDA\" on echocardiography, irrespective of clinical symptoms, or a \"moderate PDA\" on echocardiography with at least moderate clinical illness, they will receive pharmacotherapy aimed at PDA closure (The PDA severity has been divided into mild, moderate or severe based on pre-defined clinical and echocardiographic criteria).",[13],"Drug: Ibuprofen",{"label":15,"type":16,"description":17,"interventionNames":18},"Early conservative management strategy","NO_INTERVENTION","Infants randomized to this arm will not undergo any further echocardiographic assessment or pharmacological treatment of the PDA regardless of the clinical signs. If the infant gets an echocardiographic assessment for a reason different than PDA assessment (such as hypotension or oxygenation failure) and a PDA is incidentally noted that fits the treatment criteria, the infant will not be initiated on pharmacotherapy. After 7 days of age, decision on PDA assessment and treatment will be at the discretion of the treating physician.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Ibuprofen","Pharmacotherapy, when indicated (ie, for \"severe PDA\" on echocardiography, irrespective of clinical symptoms, or a \"moderate PDA\" on echocardiography with at least moderate clinical illness), will be provided in the form of ibuprofen as first line agent at a standard dosing of 10 mg\u002Fkg followed by 2 doses of 5mg\u002Fkg every 24 h. The route of administration may be intravenous or enteral, as determined by the treating team.\n\nFor treated infants, follow-up echocardiography will be conducted at the end of the 3-day course and second course of treatment will be initiated if they still fulfill study treatment criteria as mentioned above. If any treatment-eligible infant has a contraindication to ibuprofen, use of acetaminophen will be permitted as an alternative agent.",[9],[26],{"name":27,"affiliation":28,"role":29},"Souvik Mitra, MD, MSc","Dalhousie University & IWK Health","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":18,"email":34},"CONTACT","+1-902-470-6490","souvik.mitra@iwk.nshealth.ca",{"name":36,"role":32,"phone":18,"phoneExt":18,"email":37},"Amish Jain, MBBS, PhD","amish.jain@sinaihealth.ca",[39,56,66,79,96,108,123,133,138],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Children's Hospital of Orange County","RECRUITING","Orange","California","92868","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-117.85311,33.78779,{"lat":51,"lon":50},[54],{"name":55,"role":32,"phone":18,"phoneExt":18,"email":18},"John Cleary",{"facility":57,"status":58,"city":59,"state":43,"zip":60,"country":45,"countryCode":46,"cosmosGeoPoint":61,"geoPoint":65,"contacts":18},"Sharp Mary Birch Hospital for Women & Newborns","TERMINATED","San Diego","92123",{"type":48,"coordinates":62},[63,64],-117.16472,32.71571,{"lat":64,"lon":63},{"facility":67,"status":41,"city":68,"state":69,"zip":70,"country":45,"countryCode":46,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"OU College of Medicine, University of Oklahoma","Oklahoma City","Oklahoma","73117",{"type":48,"coordinates":72},[73,74],-97.51643,35.46756,{"lat":74,"lon":73},[77],{"name":78,"role":32,"phone":18,"phoneExt":18,"email":18},"Marjorie Makoni, MD",{"facility":80,"status":41,"city":81,"state":82,"zip":18,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Stollery Children's Hospital","Edmonton","Alberta","Canada","CA",{"type":48,"coordinates":86},[87,88],-113.46871,53.55014,{"lat":88,"lon":87},[91,93],{"name":92,"role":32,"phone":18,"phoneExt":18,"email":18},"Abbas Hyderi",{"name":94,"role":95,"phone":18,"phoneExt":18,"email":18},"Joseph Ting","SUB_INVESTIGATOR",{"facility":97,"status":41,"city":98,"state":99,"zip":18,"country":83,"countryCode":84,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"British Columbia Women's Hospital","Vancouver","British Columbia",{"type":48,"coordinates":101},[102,103],-123.11934,49.24966,{"lat":103,"lon":102},[106],{"name":107,"role":32,"phone":18,"phoneExt":18,"email":18},"Michael Castaldo",{"facility":109,"status":41,"city":110,"state":111,"zip":112,"country":83,"countryCode":84,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"IWK Health Center","Halifax","Nova Scotia","B3K 6R8",{"type":48,"coordinates":114},[115,116],-63.57688,44.64269,{"lat":116,"lon":115},[119,121],{"name":120,"role":32,"phone":18,"phoneExt":18,"email":18},"Souvik Mitra",{"name":122,"role":95,"phone":18,"phoneExt":18,"email":18},"Walid El-Naggar",{"facility":124,"status":125,"city":126,"state":127,"zip":18,"country":83,"countryCode":84,"cosmosGeoPoint":128,"geoPoint":132,"contacts":18},"Mount Sinai Hospital","WITHDRAWN","Toronto","Ontario",{"type":48,"coordinates":129},[130,131],-79.39864,43.70643,{"lat":131,"lon":130},{"facility":134,"status":125,"city":126,"state":127,"zip":18,"country":83,"countryCode":84,"cosmosGeoPoint":135,"geoPoint":137,"contacts":18},"Sunnybrook Health Sciences Centre",{"type":48,"coordinates":136},[130,131],{"lat":131,"lon":130},{"facility":139,"status":41,"city":140,"state":141,"zip":18,"country":83,"countryCode":84,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Centre Hospitalier Universitaire de Quebec","Québec","Quebec",{"type":48,"coordinates":143},[144,145],-71.21454,46.81228,{"lat":145,"lon":144},[148],{"name":149,"role":32,"phone":18,"phoneExt":18,"email":18},"Audrey Hébert",{"type":29,"investigatorFullName":151,"investigatorTitle":152,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Dr. Souvik Mitra, MD MSc FRCPC","Associate Professor & Neonatologist",[154,156,158,159,161,162,165,168,169,171],{"name":155,"class":6},"BC Children's Hospital Research Institute",{"name":157,"class":6},"CHU de Quebec-Universite Laval",{"name":134,"class":6},{"name":160,"class":6},"Mount Sinai Hospital, Canada",{"name":57,"class":6},{"name":163,"class":164},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV",{"name":166,"class":167},"Dalhousie Medical Research Foundation","UNKNOWN",{"name":40,"class":6},{"name":170,"class":6},"University of Alberta",{"name":172,"class":6},"University of Oklahoma","100440119","phase-3-selective-early-medical-treatment-of-patent-ductus-arteriosus-in-extremely-low-gestational-age-infants-a-pilot-rct-100440119",false,"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","ALL","72 Hours",{"count":184,"type":185},100,"ESTIMATED","INTERVENTIONAL",[188],"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.",[191],"Patent Ductus Arteriosus After Premature Birth",[193,194,195],"extremely preterm infant","early medical treatment","randomized controlled trial","2024-06-18",{"date":198,"type":199},"2024-06-21","ACTUAL",{"date":201,"type":199},"2022-01-10",{"date":203,"type":185},"2024-09-30",{"name":5,"class":6},9]