[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560113":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":229,"collaborators":42,"id":232,"slug":233,"hasResults":234,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":234,"sex":240,"minAge":241,"maxAge":242,"enrollmentInfo":243,"targetDuration":42,"studyType":246,"phases":247,"briefSummary":249,"conditions":250,"keywords":254,"overallStatus":259,"whyStopped":42,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":269},{"fullName":5,"class":6},"University of British Columbia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Single-dose prophylactic indomethacin - SPIN","EXPERIMENTAL","Infants randomized to the SPIN group will receive a single 0.1 mg\u002Fkg dose of intravenous indomethacin within 12h of birth as a slow infusion over 20 mins.",[13],"Drug: Indomethacin",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","PLACEBO_COMPARATOR","Equal volume saline placebo administered intravenously over 20 mins",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Indomethacin","Single dose of 0.1 mg\u002Fkg dose intravenous indomethacin as a slow infusion over 20 mins",[9],[27],"Indocid",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","Single dose of intravenous normal saline placebo as a slow infusion over 20 mins",[15],[33],"Normal saline",[35],{"name":36,"affiliation":5,"role":37},"Souvik Mitra, MD, PhD","PRINCIPAL_INVESTIGATOR",[39],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","6048752000",null,"souvik.mitra@cw.bc.ca",[45,62,75,89,105,113,124,133,150,162,175,186,195,204,217],{"facility":46,"status":42,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Kaiser Roseville","Roseville","California","95661","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-121.28801,38.75212,{"lat":56,"lon":55},[59],{"name":60,"role":40,"phone":42,"phoneExt":42,"email":61},"Shayna Gaman-Bean, MD","shayna.k.gaman-bean@kp.org",{"facility":63,"status":42,"city":64,"state":48,"zip":65,"country":50,"countryCode":51,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"UC Davis Health","Sacramento","95817",{"type":53,"coordinates":67},[68,69],-121.4944,38.58157,{"lat":69,"lon":68},[72],{"name":73,"role":40,"phone":42,"phoneExt":42,"email":74},"Steven McElroy, 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MD","ziad.alhassen@pediatrix.com",{"name":42,"role":40,"phone":104,"phoneExt":42,"email":42},"817-250-2000",{"facility":106,"status":42,"city":91,"state":92,"zip":93,"country":50,"countryCode":51,"cosmosGeoPoint":107,"geoPoint":109,"contacts":110},"Welcome to Baylor Scott & White Health",{"type":53,"coordinates":108},[96,97],{"lat":97,"lon":96},[111],{"name":101,"role":40,"phone":112,"phoneExt":42,"email":102},"817-926-2544",{"facility":114,"status":42,"city":115,"state":116,"zip":42,"country":117,"countryCode":118,"cosmosGeoPoint":119,"geoPoint":123,"contacts":42},"Mercy Hospital for Women","Melbourne","Victoria","Australia","AU",{"type":53,"coordinates":120},[121,122],144.96332,-37.814,{"lat":122,"lon":121},{"facility":125,"status":42,"city":115,"state":116,"zip":42,"country":117,"countryCode":118,"cosmosGeoPoint":126,"geoPoint":128,"contacts":129},"Monash Children's Hospital",{"type":53,"coordinates":127},[121,122],{"lat":122,"lon":121},[130],{"name":131,"role":40,"phone":42,"phoneExt":42,"email":132},"Calum Roberts, MBChB PhD","calum.roberts@monash.edu",{"facility":134,"status":42,"city":135,"state":136,"zip":42,"country":137,"countryCode":138,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Foothills Medical Center & Alberta Children's Hospital","Calgary","Alberta","Canada","CA",{"type":53,"coordinates":140},[141,142],-114.08529,51.05011,{"lat":142,"lon":141},[145,148],{"name":146,"role":40,"phone":42,"phoneExt":42,"email":147},"Hussein Zein, MD","hussein.zein@albertahealthservices.ca",{"name":149,"role":40,"phone":42,"phoneExt":42,"email":42},"Khorshid Mohammad, MD, MSc",{"facility":151,"status":42,"city":152,"state":136,"zip":42,"country":137,"countryCode":138,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Royal Alexandra Hospital","Edmonton",{"type":53,"coordinates":154},[155,156],-113.46871,53.55014,{"lat":156,"lon":155},[159],{"name":160,"role":40,"phone":42,"phoneExt":42,"email":161},"Georg Schmolzer, MD, PhD","georg.schmoelzer@me.com",{"facility":163,"status":42,"city":164,"state":165,"zip":42,"country":137,"countryCode":138,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"Royal Columbian Hospital","New Westminster","British Columbia",{"type":53,"coordinates":167},[168,169],-122.91092,49.20678,{"lat":169,"lon":168},[172],{"name":173,"role":40,"phone":42,"phoneExt":42,"email":174},"Miroslav Stavel, MD","miroslav.stavel@fraserhealth.ca",{"facility":176,"status":42,"city":177,"state":165,"zip":178,"country":137,"countryCode":138,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"BC Women's Hospital","Vancouver","V6H 3N1",{"type":53,"coordinates":180},[181,182],-123.11934,49.24966,{"lat":182,"lon":181},[185],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},{"facility":187,"status":42,"city":188,"state":189,"zip":42,"country":137,"countryCode":138,"cosmosGeoPoint":190,"geoPoint":194,"contacts":42},"IWK Health","Halifax","Nova Scotia",{"type":53,"coordinates":191},[192,193],-63.57688,44.64269,{"lat":193,"lon":192},{"facility":196,"status":42,"city":197,"state":198,"zip":42,"country":137,"countryCode":138,"cosmosGeoPoint":199,"geoPoint":203,"contacts":42},"Sunnybrook Health Sciences Centre","Toronto","Ontario",{"type":53,"coordinates":200},[201,202],-79.39864,43.70643,{"lat":202,"lon":201},{"facility":205,"status":42,"city":206,"state":207,"zip":42,"country":137,"countryCode":138,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Montreal Children's Hospital","Montreal","Quebec",{"type":53,"coordinates":209},[210,211],-73.58781,45.50884,{"lat":211,"lon":210},[214],{"name":215,"role":40,"phone":42,"phoneExt":42,"email":216},"Marc Beltempo, MD, MSc","marc.beltempo@mcgill.ca",{"facility":218,"status":42,"city":219,"state":207,"zip":42,"country":137,"countryCode":138,"cosmosGeoPoint":220,"geoPoint":224,"contacts":225},"CHU de Quebec","Québec",{"type":53,"coordinates":221},[222,223],-71.21454,46.81228,{"lat":223,"lon":222},[226],{"name":227,"role":40,"phone":42,"phoneExt":42,"email":228},"Audrey Hebert, MD","audrey.hebert.2@ulaval.ca",{"type":37,"investigatorFullName":230,"investigatorTitle":231,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Souvik Mitra, MD PhD","Principal Investigator","100560113","phase-2-single-dose-prophylactic-indomethacin-in-extremely-preterm-infants-100560113",false,"NCT06572917","Single-dose Prophylactic INdomethacin in Extremely Preterm Infants","Single-dose Prophylactic INdomethacin in Extremely Preterm Infants - A Multicenter Randomized Blinded Placebo-Controlled Trial (the SPIN RCT)","SPIN","Inclusion Criteria:\n\n* Extremely preterm infants born \\\u003C26 completed weeks of GA and\u002For extremely low BW infants born \\\u003C750g\n\nExclusion Criteria:\n\n* antenatal diagnosis of duct dependent CHD\n* acute hypoxic respiratory failure \\[defined as fraction of inspired oxygen (FiO2)\\>0.60 for ≥2h)\n* inhaled nitric oxide (iNO) therapy due to suspected or confirmed acute pulmonary hypertension (PH)\n* receipt of prophylactic or therapeutic hydrocortisone\n* antenatal diagnosis of renal anomalies\n* initial platelet count \\\u003C50x109\u002FL\n* decision to withhold\u002Fwithdraw life-sustaining treatments","ALL","0 Hours","12 Hours",{"count":244,"type":245},500,"ESTIMATED","INTERVENTIONAL",[248],"PHASE2","In Canada, about 900 babies each year are born very early (\\\u003C26 weeks of gestation) and have a high chance of dying or having a serious bleed in the brain. Families of these extremely preterm babies consider preventing severe brain bleeding as critical to their child's health and well-being. A medicine called indomethacin, when given intravenously in 3-doses, is known to reduce severe brain bleeding. But use of this drug is variable among clinicians working in the neonatal intensive care unit (NICU) due to (a) its side effects on the gut; (b) possible harm when used with other medications; (c) a notion that despite reducing brain bleeds, the child's long-term brain development is not improved. Emerging evidence suggests that a single low-dose indomethacin regimen may be equally effective in reducing severe brain bleeding as compared to a traditional 3-dose regimen.\n\nThe investigators propose a blinded randomized controlled trial, a study design where babies born \\\u003C26 weeks will be randomly assigned within 12 hours of birth to either a single dose of intravenous indomethacin or similar looking placebo in the form a saline solution. The study will test if a single dose indomethacin regimen is effective in improving survival of these babies without the devastating complication of severe brain bleeding. In this study the care providers and researchers will be unaware as to which baby receives indomethacin and which baby receives placebo to ensure no one's expectations or biases can influence the results.\n\nThe investigators will conduct the study in multiple NICUs across Canada, the United States and Australia in 2 phases: First, an internal pilot phase that will enroll 104 babies born \\\u003C26 weeks or \\\u003C750 g birth weight over a period of 1 year. If the investigators are successful in achieving their target enrolment in the pilot phase, they will move on to the second phase and continue enrollment up to a total of 500 babies born \\\u003C26 weeks or \\\u003C750 g birth weight over a period of 3 years. The total of 500 babies will include the 104 babies enrolled in the first phase of the study. This study will help the investigators determine in the most unbiased way whether a single dose of indomethacin given immediately after birth in the smallest babies born \\\u003C26 weeks of gestation can safely and effectively reduce severe brain bleeding.",[251,252,253],"Extreme Prematurity","Intraventricular Hemorrhage","Morbidity;Newborn",[255,256,257,258],"extremely preterm","severe intraventricular hemorrhage","mortality","prophylactic indomethacin","NOT_YET_RECRUITING","2025-08-26",{"date":262,"type":263},"2025-09-03","ACTUAL",{"date":265,"type":245},"2025-11-01",{"date":267,"type":245},"2031-03-31",{"name":5,"class":6},15]