[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100105886":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":11,"locations":27,"responsibleParty":40,"collaborators":42,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":11,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":11,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":72,"whyStopped":11,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Hopital La Rabta","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"I","ACTIVE_COMPARATOR",null,[13],"Drug: intravenous ibuprofen",{"label":15,"type":10,"description":11,"interventionNames":16},"O",[17],"Drug: oral ibuprofen",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","oral ibuprofen","one (10 mg \u002F kg), two (10 mg \u002F kg followed 24 hours after by 5 mg \u002Fkg) or three (10 mg \u002F kg followed at 24-hour intervals by two doses of 5 mg \u002Fkg each) doses of oral ibuprofen starting on the third day of life.the number of doses is depending on echocardiographic findings concerning ductal closure.",[15],{"type":20,"name":25,"description":22,"armGroupLabels":26,"otherNames":11},"intravenous ibuprofen",[9],[28],{"facility":29,"status":11,"city":30,"state":11,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":11},"Maternity and Neonatal Center","Tunis","1007","Tunisia","TN",{"type":35,"coordinates":36},"Point",[37,38],10.16579,36.81897,{"lat":38,"lon":37},{"type":11,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":41,"oldOrganization":5},"khrouf naima",[43],{"name":44,"class":45},"maternity and neonatal center","UNKNOWN","100105886","phase-4-comparative-study-of-efficacy-and-safety-of-oral-ibuprofen-and-intravenous-ibuprofen-in-closure-of-patent-ductus-arteriosus-in-very-low-birth-weight-infants-100105886",false,"NCT00642330","Comparative Study of Efficacy and Safety of Oral Ibuprofen and Intravenous Ibuprofen in Closure of Patent Ductus Arteriosus in Very Low Birth Weight Infants","Randomized Pilot Study Comparing Oral Ibuprofen With Intravenous Ibuprofen in Very Low Birth Weight Infants With Patent Ductus Arteriosus","Inclusion Criteria:\n\n* a gestational age \\\u003C 32 weeks\n* a birth weight \\\u003C 1500g\n* a postnatal age between 48 and 96 hours, a respiratory distress requiring more than 25 % of oxygen supplementation\n* an echocardiographic evidence of left to right significant shunting PDA\n\nExclusion Criteria:\n\n* a right-to-left shunting\n* major congenital anomalies\n* IVH grade 3-4\n* a tendency to bleed (defined by the presence of blood in the endotracheal aspirate, gastric aspirate, stools or urines and \u002F or oozing from puncture sites)\n* a serum creatinine level \\>140µmol\u002Fl, a serum urea nitrogen \\> 14 µmol\u002Fl and a platelet count \\\u003C 60000\u002Fmm3.","ALL","48 Hours","96 Hours",{"count":57,"type":58},62,"ACTUAL","INTERVENTIONAL",[61],"PHASE4","it is a prospective randomized simple-blinded pilot trial with the principal aim to compare efficacy and tolerance between oral ibuprofen and intravenous ibuprofen in early curative closure of PDA in very low birth weight infants. The likelihood of ductal closure with only one or two doses of treatment is a secondary objective.",[64],"Patent Ductus Arteriosus",[66,67,68,69,70,71],"patent","ductus","arteriosus","ibuprofen","premature","infant","COMPLETED","2008-03-24",{"date":75,"type":76},"2008-03-25","ESTIMATED",{"date":78,"type":11},"2007-01",{"date":80,"type":58},"2007-12",{"name":5,"class":6},1]