{ "FullStudy":{ "Rank":217821, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516398", "OrgStudyIdInfo":{ "OrgStudyId":"BPD22044" }, "Organization":{ "OrgFullName":"Stanford University", "OrgClass":"OTHER" }, "BriefTitle":"Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia", "OfficialTitle":"Endothelin-1 (ET-1) Levels as Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia (BPD)" }, "StatusModule":{ "StatusVerifiedDate":"September 2019", "OverallStatus":"Active, not recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"July 2011", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"January 2022", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"January 2022", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 19, 2012", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"September 24, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"September 26, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Christine Johnson", "ResponsiblePartyInvestigatorTitle":"Principle Investigator", "ResponsiblePartyInvestigatorAffiliation":"Stanford University" }, "LeadSponsor":{ "LeadSponsorName":"Stanford University", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"A lung condition called bronchopulmonary dysplasia (BPD) is a major cause of poor outcomes and death for premature infants. Infants with BPD are also at high risk for pulmonary hypertension (PH)—an important contributor to their condition. Previous research has suggested that a protein in the blood, endothelin-1 (ET-1), is associated with pulmonary disease.\n\nThis study aims to investigate the incidence of PH and levels of ET-1 among premature babies with BPD. It will also potentially allow us to focus further research efforts and treatment towards these infants, some of our sickest patients at LPCH.", "DetailedDescription":"This study aims to 1) investigate the incidence of PH among premature infants with BPD versus those without BPD and 2) investigate ET-1 levels in infants with BPD-associated PH versus those without BPD-associated PH. This study will allow us to help define a high-risk population at LPCH—namely, premature infants with BPD-associated PH. It will also potentially allow us to focus further research efforts and treatment targets towards these infants who encompass some of our sickest patients at LPCH.\n\nIn 2009 the Division of Lung Diseases of the National Heart, Lung and Blood Institute (NHLBI) published seven priority areas for research in pediatric pulmonary diseases, one of which was pulmonary vascular disease. An emphasis was made on finding 'clinical strategies that anticipate the development of PH [which] may allow earlier recognition and more aggressive therapy, thereby slowing the development of PH in many chronic lung parenchymal and vascular diseases'. This study attempts to address this goal. Specifically we aim to evaluate ET-1 levels in premature infants diagnosed with BPD and with BPD-associated PH. If ET-1 levels are found to correlate with disease state the possibility of prediction and possible early treatment for PH in these infants is raised and merits investigation." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Bronchopulmonary Dysplasia (BPD)", "Hypertension, Pulmonary" ] } }, "DesignModule":{ "StudyType":"Observational", "DesignInfo":{ "DesignObservationalModelList":{ "DesignObservationalModel":[ "Case-Only" ] }, "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Prospective" ] } }, "EnrollmentInfo":{ "EnrollmentCount":"60", "EnrollmentType":"Anticipated" } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Infant develops BPD", "PrimaryOutcomeTimeFrame":"36 weeks of age" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Infant develops PH", "SecondaryOutcomeTimeFrame":"36 weeks" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPremature Infants (<30 weeks EGA)\n\nExclusion Criteria:\n\nMajor congenital malformations (cardiac, respiratory, gastrointestinal)\ncongenital infection, and/or\nknown genetic syndromes (i.e. trisomy 21)", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MaximumAge":"30 Weeks", "StdAgeList":{ "StdAge":[ "Child" ] }, "StudyPopulation":"LPCH premature neonates", "SamplingMethod":"Non-Probability Sample" }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Christine Johnson, MD", "OverallOfficialAffiliation":"Stanford University", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"El Camino Hospital", "LocationCity":"Mountain View", "LocationState":"California", "LocationZip":"94040", "LocationCountry":"United States" },{ "LocationFacility":"Lucile Packard Children's Hospital at Stanford", "LocationCity":"Palo Alto", "LocationState":"California", "LocationZip":"94304", "LocationCountry":"United States" } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"Yes", "IPDSharingDescription":"Publication" } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000006976", "ConditionMeshTerm":"Hypertension, Pulmonary" },{ "ConditionMeshId":"D000001997", "ConditionMeshTerm":"Bronchopulmonary Dysplasia" },{ "ConditionMeshId":"D000006973", "ConditionMeshTerm":"Hypertension" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000014652", "ConditionAncestorTerm":"Vascular Diseases" },{ "ConditionAncestorId":"D000002318", "ConditionAncestorTerm":"Cardiovascular Diseases" },{ "ConditionAncestorId":"D000008171", "ConditionAncestorTerm":"Lung Diseases" },{ "ConditionAncestorId":"D000012140", "ConditionAncestorTerm":"Respiratory Tract Diseases" },{ "ConditionAncestorId":"D000055397", "ConditionAncestorTerm":"Ventilator-Induced Lung Injury" },{ "ConditionAncestorId":"D000055370", "ConditionAncestorTerm":"Lung Injury" },{ "ConditionAncestorId":"D000007235", "ConditionAncestorTerm":"Infant, Premature, Diseases" },{ "ConditionAncestorId":"D000007232", "ConditionAncestorTerm":"Infant, Newborn, Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M8607", "ConditionBrowseLeafName":"Hypertension", "ConditionBrowseLeafAsFound":"Hypertension", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M24456", "ConditionBrowseLeafName":"Premature Birth", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3855", "ConditionBrowseLeafName":"Bronchopulmonary Dysplasia", "ConditionBrowseLeafAsFound":"Bronchopulmonary Dysplasia", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8610", "ConditionBrowseLeafName":"Hypertension, Pulmonary", "ConditionBrowseLeafAsFound":"Hypertension, Pulmonary", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M15983", "ConditionBrowseLeafName":"Vascular Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9751", "ConditionBrowseLeafName":"Lung Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13560", "ConditionBrowseLeafName":"Respiratory Tract Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M26730", "ConditionBrowseLeafName":"Lung Injury", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M26739", "ConditionBrowseLeafName":"Ventilator-Induced Lung Injury", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8862", "ConditionBrowseLeafName":"Infant, Premature, Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8859", "ConditionBrowseLeafName":"Infant, Newborn, Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T876", "ConditionBrowseLeafName":"Bronchopulmonary Dysplasia", "ConditionBrowseLeafAsFound":"Bronchopulmonary Dysplasia", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BXS", "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions" },{ "ConditionBrowseBranchAbbrev":"BC08", "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases" },{ "ConditionBrowseBranchAbbrev":"BC16", "ConditionBrowseBranchName":"Diseases and Abnormalities at or Before Birth" },{ "ConditionBrowseBranchAbbrev":"BC26", "ConditionBrowseBranchName":"Wounds and Injuries" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }