[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559095":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":19,"centralContacts":23,"locations":28,"responsibleParty":49,"collaborators":52,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":18,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":18,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":83,"whyStopped":18,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Preterm babies","All the newborns will be studied to identify babies who will develop later (at 36 weeks of postcomptional age) Chronic Lung Disease of prematurity",[12],"Other: Blood sampling",[14],{"type":6,"name":15,"description":16,"armGroupLabels":17,"otherNames":18},"Blood sampling","\\- Collection and analysis of blood samples",[9],null,[20],{"name":21,"affiliation":5,"role":22},"Giovanni Vento","PRINCIPAL_INVESTIGATOR",[24],{"name":21,"role":25,"phone":26,"phoneExt":18,"email":27},"CONTACT","+390630153237","giovanni.vento@unicatt.it",[29],{"facility":30,"status":18,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS UOC Neonatologia","Rome","RM","00168","Italy","IT",{"type":37,"coordinates":38},"Point",[39,40],12.51133,41.89193,{"lat":40,"lon":39},[43,45,46],{"name":21,"role":25,"phone":44,"phoneExt":18,"email":27},"+39 0630153237",{"name":21,"role":22,"phone":18,"phoneExt":18,"email":18},{"name":47,"role":48,"phone":18,"phoneExt":18,"email":18},"Marco De Santis","SUB_INVESTIGATOR",{"type":22,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"VENTO GIOVANNI","Chief UOC of Neonatology",[53,55,57],{"name":54,"class":6},"Azienda Ospedaliera Universitaria Policlinico \"G. Martino\"",{"name":56,"class":6},"Azienda Ospedaliero-Universitaria di Parma",{"name":58,"class":6},"Ospedali Riuniti di Foggia","100559095","prevention-of-chronic-lung-disease-cld---prevention-study-100559095",false,"NCT06559670","Prevention of Chronic Lung Disease (CLD - Prevention Study)","Prevention of Chronic Lung Disease: New High Risk Profile for Early Detection and Management Starting From Perinatal Life (CLD - Prevention Study)","Inclusion Criteria:\n\nInfants with gestational age \\\u003C 32 weeks with at least one of the following signs of acute respiratory failure within the first 24 hours of life:\n\n* need for mechanical ventilation;\n* need for noninvasive respiratory support;\n* need for oxygen administration;\n* need for surfactant administration\n\nExclusion Criteria:\n\n* Congenital malformations\n* Neuromuscular diseases.","ALL","1 Hour","24 Hours",{"count":70,"type":71},42,"ESTIMATED","INTERVENTIONAL",[74],"NA","Primary endpoint:\n\n\\- prospectively identify potential biomarkers able to predict the severe course of pulmonary funcion in the first 12 months of life and realize a new profile to early identify hugh risk newborns\n\nSecondary endpoints:\n\n* detect genetic variance causation model (by MiSeq Illumina platform) correlating with severe pulmonary dysfunction and asthma development;\n* detect MIcroRNAs as well as anti- and pro-inflammatory cytokine variations (MIP-1α, MCP-1, IL-8, TNF-α, IFN-ɣ, IL-10) correlating with the severity of pulmonary dysfunction in the first 12 months of life and the risk of asthma development\n\nPopulation: preterm infants with gestational age \\\u003C 32 weeks who have suffered from acute respiratory insufficiency at birth\n\nIntervention:\n\n* Assessment of prenatal risk factors.\n* Collection of the following biological specimens: 1) a vaginal swab from the mothers of enrolled infants 2) a placenta sample 3) an arterial or venous cord blood sample at birth 4) peripheral blood samples from enrolled infants: the first within 48 hours of life, the subsequent ones at 7 and 28 days of life and at 6 and 12 months of age 5) bronchoalveolar lavage (BALF) samples exclusively in infants intubated for clinical reasons within the first 24 hours of life, at 7 and 28 days of life. 6) first meconium sample issued and subsequent stool samples at 7 and 28 days of life and at 6 and 12 months of age, of enrolled infants\n* Respiratory Functionality Testing at 6 and 12 months of age",[77],"Chronic Lung Disease",[77,79,80,81,82],"Newborns","COPD","Preterm infants","Bronchopulmonary dysplasia","NOT_YET_RECRUITING","2024-08-14",{"date":86,"type":87},"2024-08-19","ACTUAL",{"date":89,"type":71},"2024-09",{"date":91,"type":71},"2026-09",{"name":5,"class":6},1]