[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100444109":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":33,"locations":39,"responsibleParty":57,"collaborators":61,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":32,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":32,"overallStatus":42,"whyStopped":32,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Franciscus Gasthuis","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Broncho-Vaxom treatment","ACTIVE_COMPARATOR","Infants in this arm will be given 3,5mg bacterial lysate (OM-85) 10 days per month from 6 weeks after birth until 12 months of age.\n\nAt age 12 months they will be (if informed consent for Protea-2 is provided) randomised over Broncho-Vaxom treatment and placebo again.",[13],"Drug: Broncho-Vaxom",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Infants in this arm will be given a placebo powder from a capsule that will be indistinguishable from the active study drug.",[19],"Other: Placebo",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Broncho-Vaxom","Broncho-Vaxom is a bacterial extract comprising lyophilised fractions of 21 different inactivated bacterial strains, which are frequently causing RTI.",[9],[27,28],"OM-85","Broncho-Vaxom concentrate (Bacterial lysate)",{"type":6,"name":15,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo powder from a capsule will be given, which will be indistinguishable from the active study drug.",[15],null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Inger van Duuren","CONTACT","0031 10 893 61 69","proteastudie@franciscus.nl",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Franciscus Gasthuis & Vlietland","RECRUITING","Rotterdam","South Holland","3045PM","Netherlands","NL",{"type":49,"coordinates":50},"Point",[51,52],4.47917,51.9225,{"lat":52,"lon":51},[55],{"name":35,"role":36,"phone":56,"phoneExt":32,"email":38},"+31108936169",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Gerdien Tramper","Pediatrician\u002Fclinical researcher, principal investigator",[62,64],{"name":63,"class":6},"Leiden University Medical Center",{"name":65,"class":6},"Maastricht University Medical Center","100444109","phase-3-protecting-preterm-infants-from-respiratory-tract-infections-and-wheeze-by-using-bacterial-lysates-100444109",false,"NCT05063149","Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.","Protecting Late-moderate Preterm Infants From Respiratory Tract Infections and Wheeze in Their First Years of Life by Using Bacterial Lysates.","PROTEA","Inclusion Criteria:\n\n* Gestational age at delivery between 30+0 and 35+6 weeks\n* Postnatal age at least 6 weeks at randomization \\& postmenstrual age at least 37 weeks\n* Written informed consent by both parents or formal caregivers\n\nExclusion Criteria:\n\n* Underlying other severe respiratory disease such as broncho-pulmonary dysplasia (unexpected in this group); hemodynamic significant cardiac disease; immunodefi-ciency; severe failure to thrive; birth asphyxia with predicted poor neurological out-come; syndrome or serious congenital disorder.\n* Lower RTI before randomization\n* Dysmaturity and\u002For weight \\\u003C 2.5 kg at age of randomization.\n* Maternal TNF-alpha inhibitors or other immunosuppression during pregnancy and\u002For breastfeeding\n* Parents unable to speak and read Dutch\u002FEnglish language\n* Known allergic hypersensitivity to the active ingredients\u002Fsubstance or to any of the excipients.","ALL","6 Weeks","10 Weeks",{"count":78,"type":79},500,"ESTIMATED","INTERVENTIONAL",[82],"PHASE3","The primary objective of this study is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first years of life by bacterial lysate administration. Next to determine the correlation of biological markers with respiratory symptoms, immune protection and treatment effect.",[85,86,87],"Wheezing","LRTI","Premature","2024-08-20",{"date":90,"type":91},"2024-08-22","ACTUAL",{"date":93,"type":91},"2022-01-18",{"date":95,"type":79},"2026-12",{"name":5,"class":6},1]