[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100404035":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":24,"centralContacts":34,"locations":44,"responsibleParty":74,"collaborators":78,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":24,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":24,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":47,"whyStopped":24,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"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",[45,60],{"facility":46,"status":47,"city":48,"state":24,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Ospedali Riuniti di Ancona","RECRUITING","Ancona","60123","Italy","IT",{"type":53,"coordinates":54},"Point",[55,56],13.5103,43.60717,{"lat":56,"lon":55},[59],{"name":36,"role":37,"phone":24,"phoneExt":24,"email":39},{"facility":61,"status":62,"city":63,"state":24,"zip":64,"country":50,"countryCode":51,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Istituto di Ricerca Città della Speranza","NOT_YET_RECRUITING","Padua","35127",{"type":53,"coordinates":66},[67,68],11.88586,45.40797,{"lat":68,"lon":67},[71],{"name":72,"role":37,"phone":24,"phoneExt":24,"email":73},"Paola Cogo, MD, PHD","paola.cogo@uniud.it",{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Virgilio Paolo Carnielli","The Director of Neonatology",[79,82],{"name":80,"class":81},"Istituto di Ricerca Pediatrica Città della Speranza","UNKNOWN",{"name":83,"class":84},"Bunge Loders Croklaan","INDUSTRY","100404035","growth-of-preterm-infants-fed-a-infant-milk-formula-containing-high-versus-low-amounts-of-beta-palmitate-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":96,"type":97},150,"ESTIMATED","INTERVENTIONAL",[100],"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.",[103],"Weight Gain",[105,106,107,108,109],"Growth","Preterm Infants","Beta-palmitate","Infant formula","Human milk","2023-01-20",{"date":112,"type":113},"2023-01-25","ACTUAL",{"date":115,"type":113},"2023-01-16",{"date":117,"type":97},"2027-12",{"name":5,"class":6},2]