[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100396704":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":36,"responsibleParty":54,"collaborators":24,"id":58,"slug":24,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":24,"maxAge":65,"enrollmentInfo":66,"targetDuration":24,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":77,"overallStatus":39,"whyStopped":24,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"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,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Karolinska University Hospital","RECRUITING","Stockholm","14186","Sweden","SE",{"type":45,"coordinates":46},"Point",[47,48],18.06871,59.32938,{"lat":48,"lon":47},[51,53],{"name":27,"role":28,"phone":52,"phoneExt":30,"email":31},"0858580000",{"name":33,"role":28,"phone":52,"phoneExt":34,"email":35},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"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":67,"type":68},160,"ESTIMATED","INTERVENTIONAL",[71],"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.",[74,75,76],"RDS of Prematurity","Surfactant Deficiency Syndrome Neonatal","Analgesia",[78,9,79],"LISA (Less invasive surfactant administration)","CPAP","2025-06-26",{"date":82,"type":83},"2025-07-01","ACTUAL",{"date":85,"type":83},"2021-05-21",{"date":87,"type":68},"2026-12-31",{"name":5,"class":6},1]