[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100515587":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":294,"collaborators":296,"id":311,"slug":312,"hasResults":313,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":317,"eligibilityCriteria":318,"healthyVolunteers":313,"sex":319,"minAge":18,"maxAge":320,"enrollmentInfo":321,"targetDuration":18,"studyType":324,"phases":325,"briefSummary":327,"conditions":328,"keywords":331,"overallStatus":38,"whyStopped":18,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":353},{"fullName":5,"class":6},"PENTA Foundation","NETWORK",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Optimised kangaroo care","EXPERIMENTAL","The sites randomised in this group will adapt the study intervention consisting of:\n\nComponent 1: Skin-to-skin contact for optimised KC, describes the targeted level of early, repeated and sustained skin-to-skin contact (StSC) considered to represent optimised KC in a high-technology neonatal unit environment in which KC is already offered as part of routine care.\n\nComponent 2: Implementation Support aims to engage clinical staff in the neonatal unit who are involved in implementing StSC as part of optimised KC.",[13],"Behavioral: Optimised kangaroo care",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care","NO_INTERVENTION","The sites randomised in this group will follow the standard care, including KC and StSC sessions, treatment of severe infections\u002Fsepsis and infection prevention and control measures based on current routine local practice. Standard care in all participating NICUs already includes KC but without specific activities to ensure this is implemented according to international best practice recommendations.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"BEHAVIORAL","The intervention of optimised KC implementation consists of two components. Component 1 defines the targeted StSC for optimised KC, while component 2 is the implementation support to put in place a tailored implementation strategy.,",[9],[25],{"name":26,"affiliation":27,"role":28},"Julia Bielicki, PhD","St George's, University of London","STUDY_CHAIR",[30],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Selene Parenti","CONTACT","+39 378 309 4518","selene.parenti@pentafoundation.org",[36,52,61,69,77,89,97,102,116,128,140,152,166,178,190,200,208,216,224,232,246,258,270,282],{"facility":37,"status":38,"city":39,"state":18,"zip":18,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Aglaia Kyriakou Children's Hospital","RECRUITING","Athens","Greece","GR",{"type":43,"coordinates":44},"Point",[45,46],23.72784,37.98376,{"lat":46,"lon":45},[49],{"name":50,"role":32,"phone":18,"phoneExt":18,"email":51},"Maria Tsolia, MD","maria.n.tsolia@gmail.com",{"facility":53,"status":54,"city":55,"state":18,"zip":18,"country":40,"countryCode":41,"cosmosGeoPoint":56,"geoPoint":60,"contacts":18},"University General Hospital Attikon","COMPLETED","Attiki",{"type":43,"coordinates":57},[58,59],23.72427,38.00032,{"lat":59,"lon":58},{"facility":62,"status":54,"city":63,"state":18,"zip":18,"country":40,"countryCode":41,"cosmosGeoPoint":64,"geoPoint":68,"contacts":18},"University Hospital of Heraklion","Heraklion",{"type":43,"coordinates":65},[66,67],25.14341,35.32787,{"lat":67,"lon":66},{"facility":70,"status":54,"city":71,"state":18,"zip":18,"country":40,"countryCode":41,"cosmosGeoPoint":72,"geoPoint":76,"contacts":18},"Ioannina University Hospital","Ioannina",{"type":43,"coordinates":73},[74,75],20.85187,39.66341,{"lat":75,"lon":74},{"facility":78,"status":38,"city":79,"state":18,"zip":18,"country":40,"countryCode":41,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"University General Hospital of Patras","Pátrai",{"type":43,"coordinates":81},[82,83],21.73508,38.2462,{"lat":83,"lon":82},[86],{"name":87,"role":32,"phone":18,"phoneExt":18,"email":88},"Gabriel Dimitriou, MD","gdim@upatras.gr",{"facility":90,"status":54,"city":91,"state":18,"zip":18,"country":40,"countryCode":41,"cosmosGeoPoint":92,"geoPoint":96,"contacts":18},"Hippokration Hospital - Thessaloniki","Thessaloniki",{"type":43,"coordinates":93},[94,95],22.93493,40.64072,{"lat":95,"lon":94},{"facility":98,"status":54,"city":91,"state":18,"zip":18,"country":40,"countryCode":41,"cosmosGeoPoint":99,"geoPoint":101,"contacts":18},"Papageorgiou Hospital",{"type":43,"coordinates":100},[94,95],{"lat":95,"lon":94},{"facility":103,"status":38,"city":104,"state":18,"zip":18,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Azienda Ospedaliera Universitaria S.Anna di Ferrara","Ferrara","Italy","IT",{"type":43,"coordinates":108},[109,110],11.62057,44.83804,{"lat":110,"lon":109},[113],{"name":114,"role":32,"phone":18,"phoneExt":18,"email":115},"Silvia Fanaro, MD","fnrslv@unife.it",{"facility":117,"status":38,"city":118,"state":18,"zip":18,"country":105,"countryCode":106,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Azienda Ospedaliera Universitaria di Modena","Modena",{"type":43,"coordinates":120},[121,122],10.92539,44.64783,{"lat":122,"lon":121},[125],{"name":126,"role":32,"phone":18,"phoneExt":18,"email":127},"Alberto Berardi, MD","alberto.berardi@unimore.it",{"facility":129,"status":38,"city":130,"state":18,"zip":18,"country":105,"countryCode":106,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Ospedale Universitario Policlinico Paolo Giaccone","Palermo",{"type":43,"coordinates":132},[133,134],13.3636,38.1166,{"lat":134,"lon":133},[137],{"name":138,"role":32,"phone":18,"phoneExt":18,"email":139},"Mario Giuffrè, MD","mario.giuffre@unipa.it",{"facility":141,"status":38,"city":142,"state":18,"zip":18,"country":105,"countryCode":106,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Ospedale San Bortolo di Vicenza","Vicenza",{"type":43,"coordinates":144},[145,146],11.5475,45.54672,{"lat":146,"lon":145},[149],{"name":150,"role":32,"phone":18,"phoneExt":18,"email":151},"Stefania Vedovato, MD","stefania.vedovato@aulss8.veneto.it",{"facility":153,"status":38,"city":154,"state":18,"zip":18,"country":155,"countryCode":156,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Hospital General Universitario Alicante","Alicante","Spain","ES",{"type":43,"coordinates":158},[159,160],-0.48149,38.34517,{"lat":160,"lon":159},[163],{"name":164,"role":32,"phone":18,"phoneExt":18,"email":165},"Caridad Tapia Collados, MD","catapiac@gmail.com",{"facility":167,"status":38,"city":168,"state":18,"zip":18,"country":155,"countryCode":156,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Cruces University Hospital","Bilbao",{"type":43,"coordinates":170},[171,172],-2.92528,43.26271,{"lat":172,"lon":171},[175],{"name":176,"role":32,"phone":18,"phoneExt":18,"email":177},"Begoña Loureiro Gonzalez, MD","begona.loureirogonzalez@osakidetza.eus",{"facility":179,"status":38,"city":180,"state":18,"zip":18,"country":155,"countryCode":156,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Hospital Regional Universitario de Málaga (Carlos Haya)","Málaga",{"type":43,"coordinates":182},[183,184],-4.42034,36.72016,{"lat":184,"lon":183},[187],{"name":188,"role":32,"phone":18,"phoneExt":18,"email":189},"María C López Castillo, MD","mcarmen.lopez123@gmail.com",{"facility":191,"status":54,"city":192,"state":18,"zip":18,"country":193,"countryCode":194,"cosmosGeoPoint":195,"geoPoint":199,"contacts":18},"University of Basel Children's Hospital","Basel","Switzerland","CH",{"type":43,"coordinates":196},[197,198],7.57327,47.55839,{"lat":198,"lon":197},{"facility":201,"status":54,"city":202,"state":18,"zip":18,"country":193,"countryCode":194,"cosmosGeoPoint":203,"geoPoint":207,"contacts":18},"Inselspital - University Hospital of Bern","Bern",{"type":43,"coordinates":204},[205,206],7.44744,46.94809,{"lat":206,"lon":205},{"facility":209,"status":54,"city":210,"state":18,"zip":18,"country":193,"countryCode":194,"cosmosGeoPoint":211,"geoPoint":215,"contacts":18},"Hôpitaux Universitaires de Genève","Geneva",{"type":43,"coordinates":212},[213,214],6.14569,46.20222,{"lat":214,"lon":213},{"facility":217,"status":54,"city":218,"state":18,"zip":18,"country":193,"countryCode":194,"cosmosGeoPoint":219,"geoPoint":223,"contacts":18},"Children's Hospital of Eastern Switzerland St.Gallen","Sankt Gallen",{"type":43,"coordinates":220},[221,222],9.37477,47.42391,{"lat":222,"lon":221},{"facility":225,"status":54,"city":226,"state":18,"zip":18,"country":193,"countryCode":194,"cosmosGeoPoint":227,"geoPoint":231,"contacts":18},"Universitätsspital Zürich - University Hospital Zurich","Zurich",{"type":43,"coordinates":228},[229,230],8.55,47.36667,{"lat":230,"lon":229},{"facility":233,"status":38,"city":234,"state":18,"zip":18,"country":235,"countryCode":236,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"Birmingham Heartlands Hospital","Birmingham","United Kingdom","UK",{"type":43,"coordinates":238},[239,240],-1.89983,52.48142,{"lat":240,"lon":239},[243],{"name":244,"role":32,"phone":18,"phoneExt":18,"email":245},"Imogen Storey, MD","imogen.storey@uhb.nhs.uk",{"facility":247,"status":38,"city":248,"state":18,"zip":18,"country":235,"countryCode":236,"cosmosGeoPoint":249,"geoPoint":253,"contacts":254},"University Hospitals Coventry and Warwickshire","Coventry",{"type":43,"coordinates":250},[251,252],-1.51217,52.40656,{"lat":252,"lon":251},[255],{"name":256,"role":32,"phone":18,"phoneExt":18,"email":257},"Sarah Williamson, MD","sarah.williamson2@uhcw.nhs.uk",{"facility":259,"status":38,"city":260,"state":18,"zip":18,"country":235,"countryCode":236,"cosmosGeoPoint":261,"geoPoint":265,"contacts":266},"City St George's, University of London","London",{"type":43,"coordinates":262},[263,264],-0.12574,51.50853,{"lat":264,"lon":263},[267],{"name":268,"role":32,"phone":18,"phoneExt":18,"email":269},"Amy Reid, MD","amy.reid@stgeorges.nhs.uk",{"facility":271,"status":38,"city":272,"state":18,"zip":18,"country":235,"countryCode":236,"cosmosGeoPoint":273,"geoPoint":277,"contacts":278},"St Mary's Hospital","Manchester",{"type":43,"coordinates":274},[275,276],-2.23743,53.48095,{"lat":276,"lon":275},[279],{"name":280,"role":32,"phone":18,"phoneExt":18,"email":281},"Susan Dowd, MD","susan.dowd@mft.nhs.uk",{"facility":283,"status":38,"city":284,"state":18,"zip":18,"country":235,"countryCode":236,"cosmosGeoPoint":285,"geoPoint":289,"contacts":290},"Norfolk and Norwich University Hospital NHS Foundation Trust","Norwich",{"type":43,"coordinates":286},[287,288],1.29834,52.62783,{"lat":288,"lon":287},[291],{"name":292,"role":32,"phone":18,"phoneExt":18,"email":293},"Paul Clarke, MD","paul.clarke@nnuh.nhs.uk",{"type":295,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[297,300,302,304,306,308,310],{"name":298,"class":299},"European Clinical Research Alliance for Infectious Diseases (ECRAID)","OTHER",{"name":301,"class":299},"University of Zurich",{"name":303,"class":299},"Universiteit Antwerpen",{"name":305,"class":299},"Charite University, Berlin, Germany",{"name":307,"class":299},"UMC Utrecht",{"name":309,"class":299},"Swiss Tropical & Public Health Institute",{"name":27,"class":299},"100515587","optimising-kangaroo-care-to-reduce-neonatal-severe-infectionsepsis-and-resistant-bacterial-colonisation-among-high-risk-infants-in-nicu-100515587",false,"NCT05993442","Optimising Kangaroo Care to Reduce Neonatal Severe Infection\u002FSepsis and Resistant Bacterial Colonisation Among High-risk Infants in NICU.","Optimising Kangaroo Care to Reduce Neonatal Severe Infection\u002FSepsis and Resistant Bacterial Colonisation Among High-risk Infants in Neonatal Intensive Care: a Pragmatic, Multicentre, Parallel Cluster Randomised Hybrid Implementation-effectiveness Study.","NeoDeco","INCLUSION CRITERIA\n\n1\\. Site level\n\n1a. Neonatal unit that provide routinely cares for extremely premature infants (\\\u003C28 weeks' gestation).\n\n1b. Minimum capacity of 12 beds.\n\n1c. Access to a -70 to -80°C freezer for storage of research samples\n\n1d. Willing to implement optimised KC if allocated to the intervention group.\n\n1e. Willing to commit to offering the minimum expected target duration or an increase of 50% if neonatal unit is already offering \\>67% of the minimum expected target duration, if allocated to the intervention arm.\n\n1f. Prepared to implement NeoIPC surveillance.\n\n1. g. Adequate resources and expertise and approvals from relevant Research Ethics Committees, as appropriate.\n2. Infant level\n\n2a. All high-risk infants (born at \\\u003C32 weeks' gestation) admitted to participating neonatal units, regardless of complexity of care, anticipated hospitalisation duration, room type, or whether admitted directly after birth.\n\nEXCLUSION CRITERIA 1 Site level\n\n1. a. Participation in other research that could directly influence the study intervention or outcomes.\n2. a. Average StSC duration already exceeding 18 hours per day.\n3. a. Anticipated major changes in resistant bacterial colonisation pressure during the study\n\n2 Infant level 2a. No infant-level exclusion criteria for data collection. We exclude infants from individual data and sample collection if their parents or legal guardians do not provide written informed consent. These infants contribute to cluster-aggregated outcomes.","ALL","32 Weeks",{"count":322,"type":323},3080,"ESTIMATED","INTERVENTIONAL",[326],"NA","NeoDeco is a pragmatic, multicenter, parallel-group, cluster-randomised hybrid effectiveness-implementation trial designed to evaluate the impact of implementing optimised Kangaroo Care (KC) at the unit level compared to standard care in high-technology neonatal units. The trial includes a baseline period, a wash-in phase, and a staggered randomisation approach. The primary focus of the NeoDeco study is on high-risk preterm infants born at less than 32 weeks' gestational age, a population particularly vulnerable to hospital-acquired infections and sepsis during their initial hospital stay. By investigating hospital-acquired infections specifically, the study targets the period during which optimised KC practices are likely to have the most significant impact.",[329,330],"Infection, Bacterial","Infection Prevention",[332,333,334,335,336,337,338,339,340,341,342,343],"Nosocomial Infection","Prevention","Cluster","Implementation science","Surveillance","Kangaroo Care","Skin to Skin Contact","Neonatal Intensive Care Unit","NICU","Neonatal severe infection","Resistant bacterial","Pre-term infants","2026-03-20",{"date":346,"type":347},"2026-03-25","ACTUAL",{"date":349,"type":347},"2024-05-28",{"date":351,"type":323},"2026-05",{"name":5,"class":6},24]