[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100396704":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":36,"responsibleParty":53,"collaborators":24,"id":57,"slug":24,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":24,"maxAge":64,"enrollmentInfo":65,"targetDuration":24,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":39,"whyStopped":24,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"INSURE","ACTIVE_COMPARATOR","Surfactant administration by Intubation-surfactant-extubation to CPAP according to standard protocol including premedication with analgesia and sedation.",[13],"Procedure: Thin catheter technique or standard ET-tube for surfactant administration",{"label":15,"type":10,"description":16,"interventionNames":17},"LISA","Surfactant administration by thin catheter during spontaneous breathing and continued CPAP according to set protocol including premedication with analgesia.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Thin catheter technique or standard ET-tube for surfactant administration","Surfactant administration by intubation with regular ET-tube followed by immediate extubation to CPAP (INSURE) or by thin catheter during spontaneous breathing and continued CPAP.",[9,15],null,[26,32],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Kajsa Bohlin, MD","CONTACT","+46858580000","81356","kajsa.bohlin@ki.se",{"name":33,"role":28,"phone":29,"phoneExt":34,"email":35},"Mats Blennow, MD","81428","mats.blennow@ki.se",[37],{"facility":38,"status":39,"city":40,"state":24,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Karolinska University Hospital","RECRUITING","Stockholm","14186","Sweden",{"type":44,"coordinates":45},"Point",[46,47],18.06871,59.32938,{"lat":47,"lon":46},[50,52],{"name":27,"role":28,"phone":51,"phoneExt":30,"email":31},"0858580000",{"name":33,"role":28,"phone":51,"phoneExt":34,"email":35},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Kajsa Bohlin","MD, PhD","100396704",false,"NCT04445571","Surfactant Administration by Insure or Thin Catheter","SAINT","Inclusion Criteria:\n\n* Infants born before 32 completed weeks of gestation on CPAP, with clinical and radiological signs of RDS and need for surfactant treatment.\n\nExclusion Criteria:\n\n* Infants requiring surfactant as part of delivery room resuscitation are not eligible.\n\nInfants will be excluded from the final analysis if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation, including: congenital diaphragmatic hernia; tracheo-oesophageal fistula or cyanotic heart disease.","ALL","2 Days",{"count":66,"type":67},160,"ESTIMATED","INTERVENTIONAL",[70],"NA","This trial evaluates the efficacy and safety of surfactant administration with thin catheter technique together with analgesic premedication in comparison with the established INSURE-strategy. It will provide valuable knowledge to improve clinical methodology and enhance lung protective treatment strategies for preterm infants.",[73,74,75],"RDS of Prematurity","Surfactant Deficiency Syndrome Neonatal","Analgesia",[77,9,78],"LISA (Less invasive surfactant administration)","CPAP","2025-06-26",{"date":81,"type":82},"2025-07-01","ACTUAL",{"date":84,"type":82},"2021-05-21",{"date":86,"type":67},"2026-12-31",{"name":5,"class":6},1]