[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100404035":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":24,"centralContacts":34,"locations":44,"responsibleParty":73,"collaborators":77,"id":84,"slug":24,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":24,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":24,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":47,"whyStopped":24,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Ospedali Riuniti Ancona","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"EX_IMF group","EXPERIMENTAL","Infants will receive infants formula with large amounts of beta-palmitate (EX\\_IMF).",[13],"Other: EX_IMF",{"label":15,"type":16,"description":17,"interventionNames":18},"ST_IMF group","ACTIVE_COMPARATOR","Infants will receive infants formula with low amounts of beta-palmitate (ST\\_IMF).",[19],"Other: ST_IMF",{"label":21,"type":22,"description":23,"interventionNames":24},"HM group","NO_INTERVENTION","Infants will receive human milk (HM).",null,[26,30],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":24},"EX_IMF","Infant formula with large amounts of beta-palmitate (about 60%).",[9],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":24},"ST_IMF","Infant formula with low amounts beta-palmitate (about 10%).",[15],[35,40],{"name":36,"role":37,"phone":38,"phoneExt":24,"email":39},"Virgilio Carnielli, MD, PHD","CONTACT","0715962045","v.carnielli@staff.univpm.it",{"name":41,"role":37,"phone":42,"phoneExt":24,"email":43},"Alessio Correani, MSc, PHD","0715962888","a.correani@pm.univpm.it",[45,59],{"facility":46,"status":47,"city":48,"state":24,"zip":49,"country":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Ospedali Riuniti di Ancona","RECRUITING","Ancona","60123","Italy",{"type":52,"coordinates":53},"Point",[54,55],13.5103,43.60717,{"lat":55,"lon":54},[58],{"name":36,"role":37,"phone":24,"phoneExt":24,"email":39},{"facility":60,"status":61,"city":62,"state":24,"zip":63,"country":50,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Istituto di Ricerca Città della Speranza","NOT_YET_RECRUITING","Padua","35127",{"type":52,"coordinates":65},[66,67],11.88586,45.40797,{"lat":67,"lon":66},[70],{"name":71,"role":37,"phone":24,"phoneExt":24,"email":72},"Paola Cogo, MD, PHD","paola.cogo@uniud.it",{"type":74,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Virgilio Paolo Carnielli","The Director of Neonatology",[78,81],{"name":79,"class":80},"Istituto di Ricerca Pediatrica Città della Speranza","UNKNOWN",{"name":82,"class":83},"Bunge Loders Croklaan","INDUSTRY","100404035",false,"NCT04541095","Growth of Preterm Infants Fed a Infant Milk Formula Containing High Versus Low Amounts of Beta-palmitate","A Randomized, Multicenter, Controlled Clinical Trial to Assess Weight Gain of Preterm Infants Fed a New Infant Milk Formula Containing High Amounts of Beta-palmitate Versus a Standard Infant Milk Formula Containing Low Amounts of Beta-palmitate","Inclusion Criteria:\n\n* gestational age between 24 and 32 weeks of gestation at enrollment,\n* birth weight greater than 750 grams,\n* singleton or twin birth (no triplet or higher),\n* fraction of inspired oxygen lower than 0.60 at enrollment,\n* feasible enteral feeding,\n* cardiovascular stable condition,\n* informed consent form signed by at least one parent or legal guardian.\n\nExclusion Criteria:\n\n* congenital malformations, genetic, metabolic and endocrine disorders,\n* suspicious infection at enrollment,\n* intrauterine growth restriction (\\\u003C10th centile) at enrollment,\n* maternal diabetes requiring insulin therapy,\n* neonatal asphyxia.","ALL","24 Weeks","32 Weeks",{"count":94,"type":95},150,"ESTIMATED","INTERVENTIONAL",[98],"NA","The aim of this study is to assess weight gain of preterm infants (gestational age lower than 32 weeks) fed infant milk formula with about 60% beta-palmitate (EX\\_IMF) vs infant milk formula with similar macronutrient, mineral and fatty acid composition but lower amounts of beta-palmitate (ST\\_IMF). Own mother milk (OMM) fed infants will serve as reference group.",[101],"Weight Gain",[103,104,105,106,107],"Growth","Preterm Infants","Beta-palmitate","Infant formula","Human milk","2023-01-20",{"date":110,"type":111},"2023-01-25","ACTUAL",{"date":113,"type":111},"2023-01-16",{"date":115,"type":95},"2027-12",{"name":5,"class":6},2]