[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613069":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":54,"collaborators":25,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":83,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Medical University of Graz","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"1-Minute Administration (\"1-min\"-group)","EXPERIMENTAL","Infants receive poractant alfa (Curosurf®) administered via the LISA technique over 1 minute.",[13],"Drug: Poractant alfa (Curosurf®) - 1-minute administration",{"label":15,"type":10,"description":16,"interventionNames":17},"5-Minute Administration (\"5-min\"-group)","Infants receive poractant alfa (Curosurf®) administered via the LISA technique over 5 minutes.",[18],"Drug: Poractant alfa (Curosurf®) - 5-minute administration",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Poractant alfa (Curosurf®) - 1-minute administration","Poractant alfa (Curosurf®, Chiesi Pharmaceuticals) administered intratracheally via the Less Invasive Surfactant Administration (LISA) technique over 1 minute.\n\nThe surfactant is instilled manually through a thin catheter under direct laryngoscopy while the infant remains on continuous positive airway pressure (CPAP) and spontaneous breathing.\n\nPre-specified criteria for aborting the LISA procedure are prolonged bradycardia (HR \\\u003C 80 bpm) and\u002For arterial hypoxia (SpO2 \\\u003C 80%) over 60 seconds during surfactant administration starting after the instillation of the LISA catheter. Data of included participants with discontinuation will be collected and analysed.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Poractant alfa (Curosurf®) - 5-minute administration","Poractant alfa (Curosurf®, Chiesi Pharmaceuticals) administered intratracheally via the Less Invasive Surfactant Administration (LISA) technique over 5 minute.\n\nThe surfactant is instilled manually through a thin catheter under direct laryngoscopy while the infant remains on continuous positive airway pressure (CPAP) and spontaneous breathing.\n\nPre-specified criteria for aborting the LISA procedure are prolonged bradycardia (HR \\\u003C 80 bpm) and\u002For arterial hypoxia (SpO2 \\\u003C 80%) over 60 seconds during surfactant administration starting after the instillation of the LISA catheter. Data of included participants with discontinuation will be collected and analysed.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Christina H. Wolfsberger, Priv.Doz. DDr.","CONTACT","+43 316 385 81135","christina.wolfsberger@medunigraz.at",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Gerhard Pichler, Univ.Prof. PD. Dr.","+43 316 385 80520","gerhard.pichler@medunigraz.at",[41],{"facility":42,"status":43,"city":44,"state":25,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":25},"Medical University of Graz, Division of Neonatology, Department of Pediatrics and Adolescent Medicine","RECRUITING","Graz","8036","Austria","AT",{"type":49,"coordinates":50},"Point",[51,52],15.44197,47.06733,{"lat":52,"lon":51},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Christina Wolfsberger, MD","Priv.Doz. DDr.","100613069","phase-4-duration-of-surfactant-administration-and-impact-on-stabilisation-of-vital-parameters-in-very-preterm-neonates-1-minutes-versus-5-minutes-100613069",false,"NCT07261787","Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes","Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minute Versus 5 Minutes - a Prospective Randomised-controlled Phase IV Trial - A Randomised Clinical Trial on Influence of Duration of Surfactant Administration on Stabilisation of Routine Monitoring Parameters and Cerebral Tissue Oxygen Saturation Monitoring in Preterm Neonates \u003C 28 Weeks of Gestational Age","SurfStab I","Inclusion Criteria:\n\n* Preterm neonate \\\u003C28+0 weeks (gestational age up to 27 weeks and 6 days)\n* Indication of surfactant administration via the LISA method\n* Postnatal age \\\u003C 72 hours\n\nExclusion Criteria:\n\n* Invasive ventilation, indication of INSURE procedure\n* Severe pulmonary or cardiac malformation affecting oxygenation or congenital cerebral malformation\n* Preexisiting diagnose of any IVH \\> grade 2 or PVH.","ALL","0 Months","72 Hours",{"count":70,"type":71},76,"ESTIMATED","INTERVENTIONAL",[74],"PHASE4","Respiratory distress syndrome (RDS) is common in very preterm infants due to surfactant deficiency. Surfactant replacement therapy is lifesaving, and current guidelines recommend the less invasive surfactant administration (LISA) technique. However, the optimal duration of surfactant instillation during LISA has never been systematically evaluated. Rapid instillation may provoke transient hypoxia and bradycardia, while slower administration might improve physiological stability and cerebral oxygenation.\n\nThis randomised controlled trial investigates whether the duration of surfactant administration (1 minute versus 5 minutes) affects cerebral and systemic oxygen stability in extremely preterm neonates (\\\u003C 28 weeks).",[77,78,79,80,81,82],"Neonates and Preterm Infants","Infant Respiratory Distress Syndrome","Surfactant Deficiency Syndrome Neonatal","Surfactant","Cerebral Oxygenation","Cerebral Oxygen Saturation",[84,85,86,87,88,89,90],"surfactant","surfactant administration","LISA","less-invasive surfactant administration","preterm neonates","cerebral oxygenation","near-infrared spectroscopy","2026-05-12",{"date":93,"type":94},"2026-05-14","ACTUAL",{"date":96,"type":94},"2026-02-20",{"date":98,"type":71},"2028-12-01",{"name":5,"class":6},1]