[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486115":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":43,"centralContacts":47,"locations":56,"responsibleParty":114,"collaborators":28,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":119,"sex":125,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":28,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":28,"overallStatus":72,"whyStopped":28,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Fentanyl group","ACTIVE_COMPARATOR","Patients will receive 0.5-1 mcg\u002Fkg fentanyl intravenously as pre-procedure analgesia for Less Invasive Surfactant Administration (LISA).\n\nThe staff will perform LISA using standard pre- and post-procedure care, including non-pharmacological treatment and the use of atropine, caffeine, and naloxone at the clinician's discretion, based on local protocols and guidelines. All medications will be registered.",[13,14,15],"Procedure: Less Invasive Surfactant Administration (LISA)","Drug: Fentanyl","Behavioral: Non-pharmacological standard operating procedure",{"label":17,"type":18,"description":19,"interventionNames":20},"Saline group","SHAM_COMPARATOR","Patients will receive a placebo (isotonic saline) instead of pre-procedure analgesia for Less Invasive Surfactant Administration (LISA).\n\nThe staff will perform LISA using standard pre- and post-procedure care, including non-pharmacological treatment and the use of atropine, caffeine, and naloxone at the clinician's discretion, based on local protocols and guidelines. All medications will be registered.",[21,13,15],"Drug: Isotonic saline",[23,29,34,38],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Isotonic saline","Isotonic saline will be administered intravenously instead of pre-procedure analgesia.",[17],null,{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":28},"PROCEDURE","Less Invasive Surfactant Administration (LISA)","All infants will be treated with the Less Invasive Surfactant Administration (LISA) procedure",[9,17],{"type":24,"name":35,"description":36,"armGroupLabels":37,"otherNames":28},"Fentanyl","Fentanyl 0.5-1.0 mcg\u002Fkg will be administered intravenously as pre-procedure analgesia",[9],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":28},"BEHAVIORAL","Non-pharmacological standard operating procedure","All infants will receive the same non-pharmacological standard operating procedure.",[9,17],[44],{"name":45,"affiliation":5,"role":46},"Niklas Breindahl, MD","PRINCIPAL_INVESTIGATOR",[48,53],{"name":49,"role":50,"phone":51,"phoneExt":28,"email":52},"Lise Aunsholt, MD, PhD","CONTACT","+4561991137","lise.aunsholt@regionh.dk",{"name":45,"role":50,"phone":54,"phoneExt":28,"email":55},"+4528566410","niklas.breindahl@regionh.dk",[57,70,86,98],{"facility":58,"status":59,"city":60,"state":28,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":28},"Neonatalafsnittet, Børn- og Ungeafdelingen, Reberbansgade 15","WITHDRAWN","Aalborg","9000","Denmark","DK",{"type":65,"coordinates":66},"Point",[67,68],9.9187,57.048,{"lat":68,"lon":67},{"facility":71,"status":72,"city":73,"state":28,"zip":74,"country":62,"countryCode":63,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Department of Paediatrics (Intensive Care Neonatology) and Perinatal Research Unit","RECRUITING","Aarhus","8200",{"type":65,"coordinates":76},[77,78],10.21076,56.15674,{"lat":78,"lon":77},[81,84],{"name":82,"role":50,"phone":28,"phoneExt":28,"email":83},"Tine B Henriksen, MD, PhD","tine.brink.henriksen@clin.au.dk",{"name":85,"role":50,"phone":28,"phoneExt":28,"email":28},"Peter Agergaard, MD",{"facility":87,"status":72,"city":88,"state":28,"zip":89,"country":62,"countryCode":63,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Department of Neonatal and Pediatric Intensive Care, Blegdamsvej 9","Copenhagen","2100",{"type":65,"coordinates":91},[92,93],12.56553,55.67594,{"lat":93,"lon":92},[96,97],{"name":49,"role":50,"phone":28,"phoneExt":28,"email":52},{"name":45,"role":50,"phone":28,"phoneExt":28,"email":28},{"facility":99,"status":100,"city":101,"state":28,"zip":102,"country":62,"countryCode":63,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"H.C. Andersen Børne- og Ungehospital, Kløvervænget 23C, Indgang 60","NOT_YET_RECRUITING","Odense","5000",{"type":65,"coordinates":104},[105,106],10.38831,55.39594,{"lat":106,"lon":105},[109,112],{"name":110,"role":50,"phone":28,"phoneExt":28,"email":111},"Gitte Zachariassen, MD, PhD","Gitte.Zachariassen@rsyd.dk",{"name":113,"role":50,"phone":28,"phoneExt":28,"email":28},"Stine Lund, MD",{"type":46,"investigatorFullName":115,"investigatorTitle":116,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Lise Aunsholt","MD, PhD, associate professor","100486115","the-nona-lisa-trial-100486115",false,"NCT05609877","The NONA-LISA Trial","NON-pharmacological Approach Less Invasive Surfactant Administration (NONA-LISA) Trial: Protocol for a Randomised Controlled Trial","NONA-LISA","Inclusion Criteria:\n\n* Infants born at one of the trial sites with a gestational age of 24+0 to 29+6 weeks and meeting the criteria for first-choice surfactant treatment by LISA as described by Sweet et al.: worsening babies with RDS and FiO2 \\> 0.30 on CPAP pressure ≥6 cm H2O.\n\nExclusion Criteria:\n\n1. suspicion of lung hypoplasia,\n2. endotracheal intubation at any time before randomisation,\n3. suspicion of pneumothorax, pulmonary haemorrhage or pleural effusion before LISA,\n4. major congenital anatomical anomalies as described by the European Surveillance of Congenital Anomalies (EUROCAT).","ALL","24 Weeks","30 Weeks",{"count":129,"type":130},324,"ESTIMATED","INTERVENTIONAL",[133],"NA","The NONA-LISA trial will be an investigator-initiated, multicentre, pragmatic, parallel-group, blinded RCT conducted at four university hospitals across Denmark. A total of 324 inborn premature infants will be included within 36 months at four neonatal intensive care units (NICUs) across Denmark (approximately 2 infants per month per unit).\n\nThe aim is to compare LISA using a non-pharmacological approach alone with routine analgesic treatment combined with a non-pharmacological approach (according to local guidelines) regarding LISA failure defined as the need for positive pressure ventilation for 30 min or more (cumulated) within 24 hours after the procedure in infants born prior to 30 gestational weeks.",[136],"Respiratory Distress Syndrome in Premature Infant","2024-09-18",{"date":139,"type":140},"2024-09-20","ACTUAL",{"date":142,"type":140},"2024-06-01",{"date":144,"type":130},"2029-05-31",{"name":5,"class":6},4]