{ "FullStudy":{ "Rank":218165, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511887", "OrgStudyIdInfo":{ "OrgStudyId":"Ibuprofen in PDA" }, "Organization":{ "OrgFullName":"Hormozgan University of Medical Sciences", "OrgClass":"OTHER" }, "BriefTitle":"Safety and Efficacy of Ibuprofen in Term Newborns With Patent Ductus Arteriosus (PDA)", "OfficialTitle":"Evaluation of the Safety and Efficacy of Oral Ibuprofen in Term 20-28 Days Old Newborns Referred to Bandar Abbass Children Hospital in 2011" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2011", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"January 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 13, 2012", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 19, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 20, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Hamidreza Mahboobi", "ResponsiblePartyInvestigatorTitle":"Principal Investigator", "ResponsiblePartyInvestigatorAffiliation":"Hormozgan University of Medical Sciences" }, "LeadSponsor":{ "LeadSponsorName":"Hormozgan University of Medical Sciences", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The aim of current study is to evaluate the efficacy and safety of oral Ibuprofen in term 20-28 days old newborn referred to Bandarabbas children' hospital in 2011.", "DetailedDescription":"Patent Ductus Arteriosus (PDA) accounts for about 10% of Congenital Heart Disease. Surgical treatment in PDA is associated with higher rate of complication than pharmacologic treatment. Efficacy of Ibuprofen is shown in preterm and low birth weights newborn with PDA. Studies in term neonates after the first days of birth are rare. The aim of current study is to evaluate the efficacy and safety of oral Ibuprofen in term 20-28 days old newborn referred to Bandarabbas children' hospital in 2011." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Patent Ductus Arteriosus" ] }, "KeywordList":{ "Keyword":[ "Patent Ductus Arteriosus", "PDA", "Term newborns", "Ibuprofen" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"40", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Oral Ibuprofen", "ArmGroupType":"Experimental", "ArmGroupDescription":"10mg/kg oral ibuprofen followed by two 5mg/kg in 12 hours intervals. If there was no improvement after first cycle of treatment this treatment was repeated.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Oral Ibuprofen" ] } },{ "ArmGroupLabel":"No treatment", "ArmGroupType":"No Intervention", "ArmGroupDescription":"No treatment" } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Oral Ibuprofen", "InterventionDescription":"10mg/kg oral ibuprofen followed by two 5mg/kg in 12 hours intervals. If there was no improvement after first cycle of treatment this treatment was repeated.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Oral Ibuprofen" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Advil" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"PDA closure after 1 week", "PrimaryOutcomeDescription":"PDA closure after 1 week of treatment based on echocardiography", "PrimaryOutcomeTimeFrame":"1 weeks after treatment" },{ "PrimaryOutcomeMeasure":"PDA closure after two weeks", "PrimaryOutcomeDescription":"PDA closure two weeks after treatment based on echocardiography", "PrimaryOutcomeTimeFrame":"2 weeks after treatment" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Drug side effects", "SecondaryOutcomeDescription":"hemorrhage, abdominal distention, oliguria", "SecondaryOutcomeTimeFrame":"two weeks after treatment" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nTerm newborn (37 weeks of gestation or more)\nAge between 20-28 days\nconfirmed diagnosis of PDA by echocardiography by pediatric cardiologist\n\nExclusion Criteria:\n\nAsphyxia\nHemorrhage\nPlatelet count < 150000\nrenal or gastrointestinal malformations\nassociated congenital heart disease", "HealthyVolunteers":"No", "Gender":"All", "MaximumAge":"28 Days", "StdAgeList":{ "StdAge":[ "Child" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Hamidreza Mahboobi, MD", "OverallOfficialAffiliation":"Hormozgan University of Medical Sciences (HUMS)", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Hormozgan University of Medical Sciences", "LocationCity":"Bandar Abbas", "LocationState":"Hormozgan", "LocationZip":"097145-3388", "LocationCountry":"Iran, Islamic Republic of" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000007052", "InterventionMeshTerm":"Ibuprofen" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000894", "InterventionAncestorTerm":"Anti-Inflammatory Agents, Non-Steroidal" },{ "InterventionAncestorId":"D000018712", "InterventionAncestorTerm":"Analgesics, Non-Narcotic" },{ "InterventionAncestorId":"D000000700", "InterventionAncestorTerm":"Analgesics" },{ "InterventionAncestorId":"D000018689", "InterventionAncestorTerm":"Sensory System Agents" },{ "InterventionAncestorId":"D000018373", "InterventionAncestorTerm":"Peripheral Nervous System Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000000893", "InterventionAncestorTerm":"Anti-Inflammatory Agents" },{ "InterventionAncestorId":"D000018501", "InterventionAncestorTerm":"Antirheumatic Agents" },{ "InterventionAncestorId":"D000016861", "InterventionAncestorTerm":"Cyclooxygenase Inhibitors" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M8685", "InterventionBrowseLeafName":"Ibuprofen", "InterventionBrowseLeafAsFound":"Ibuprofen", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2799", "InterventionBrowseLeafName":"Anti-Inflammatory Agents, Non-Steroidal", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2798", "InterventionBrowseLeafName":"Anti-Inflammatory Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2613", "InterventionBrowseLeafName":"Analgesics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19370", "InterventionBrowseLeafName":"Analgesics, Non-Narcotic", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19188", "InterventionBrowseLeafName":"Antirheumatic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M17792", "InterventionBrowseLeafName":"Cyclooxygenase Inhibitors", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Infl", "InterventionBrowseBranchName":"Anti-Inflammatory Agents" },{ "InterventionBrowseBranchAbbrev":"ARhu", "InterventionBrowseBranchName":"Antirheumatic Agents" },{ "InterventionBrowseBranchAbbrev":"Analg", "InterventionBrowseBranchName":"Analgesics" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000004374", "ConditionMeshTerm":"Ductus Arteriosus, Patent" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000006330", "ConditionAncestorTerm":"Heart Defects, Congenital" },{ "ConditionAncestorId":"D000018376", "ConditionAncestorTerm":"Cardiovascular Abnormalities" },{ "ConditionAncestorId":"D000002318", "ConditionAncestorTerm":"Cardiovascular Diseases" },{ "ConditionAncestorId":"D000006331", "ConditionAncestorTerm":"Heart Diseases" },{ "ConditionAncestorId":"D000000013", "ConditionAncestorTerm":"Congenital Abnormalities" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M6131", "ConditionBrowseLeafName":"Ductus Arteriosus, Patent", "ConditionBrowseLeafAsFound":"Patent Ductus Arteriosus", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8001", "ConditionBrowseLeafName":"Heart Defects, Congenital", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M12", "ConditionBrowseLeafName":"Congenital Abnormalities", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M19087", "ConditionBrowseLeafName":"Cardiovascular Abnormalities", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8002", "ConditionBrowseLeafName":"Heart Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T4478", "ConditionBrowseLeafName":"Patent Ductus Arteriosus", "ConditionBrowseLeafAsFound":"Patent Ductus Arteriosus", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"BC16", "ConditionBrowseBranchName":"Diseases and Abnormalities at or Before Birth" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }