[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557859":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":12,"responsibleParty":31,"collaborators":12,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":41,"eligibilityCriteria":42,"healthyVolunteers":37,"sex":43,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":12,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":12,"overallStatus":55,"whyStopped":12,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":12},{"fullName":5,"class":6},"Charles University, Czech Republic","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"ARM A (CPAP group)","NO_INTERVENTION","Infants randomized to the ARM A group will be stabilized on CPAP, according to the standard procedure of each participating center.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"ARM B (HFNC group)","EXPERIMENTAL","For infants randomly assigned to the ARM B group, the respiratory support will be provided by devices that deliver a blend of heated and humidified gas mixture of air and oxygen at gas flows exceeding 8 L\u002F min via binasal cannula.",[18],"Device: High-flow-nasal-cannula",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DEVICE","High-flow-nasal-cannula","Respiratory support will be provided by devices that deliver a blend of heated and humidified gas mixture of air and oxygen at gas flows exceeding 8 L\u002F min via binasal cannula.",[14],[26],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Tereza Lamberska, PhD","CONTACT","+4202249674444","tereza.lamberska@vfn.cz",{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Jonáš Klára","Investigator","100557859","comparing-of-high-flow-nasal-cannula-versus-cpap-for-initial-respiratory-stabilisation-of-very-premature-infants-100557859",false,"NCT06543589","Comparing of High Flow Nasal Cannula Versus Cpap for Initial Respiratory Stabilisation of Very Premature Infants","A Randomised Trial Comparing of High Flow Nasal Cannula Versus Cpap for Initial Respiratory Stabilisation of Very Premature Infants","SIMPLSAFE3","Inclusion Criteria:\n\n* Gestational age at birth between 28+0 and 31+6 weeks by the best obstetric estimate.\n* Written informed consent from parent\u002Flegal guardian(s) is obtained before delivery.\n\nExclusion Criteria:\n\n* Peripartal hypoxia with pH \\\u003C 7,1\n* Significant congenital malformations.\n* IUGR with estimated weight of fetus below 800g.\n* Condition that has an adverse effect on breathing\u002Fventilation or oxygenation, including congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanotic heart disease and surfactant protein deficiency.\n* Documented decision to give palliative neonatal care.","ALL","1 Minute","5 Minutes",{"count":47,"type":48},443,"ESTIMATED","INTERVENTIONAL",[51],"NA","Non-invasive continuous positive airway pressure (CPAP) stabilizes premature newborns, but its optimal pressure is unknown. High-flow nasal cannula (HFNC) is an alternative that minimizes trigeminal stimulation but lacks precise pressure control. Initial studies show HFNC's feasibility and effectiveness. This study hypothesizes that HFNC can deliver adequate pressure, reduce the need for positive pressure ventilation, and support safe stabilization of very premature infants. The trial compares the effectiveness and safety of HFNC versus CPAP in the delivery room and during transport to the neonatal intensive care unit in very premature infants. The primary objective is to compare HFNC and CPAP in reducing the need for positive pressure ventilation in very premature infants immediately after birth. The study includes very premature infants delivered between 28+0 and 31+6 weeks gestation in 10 tertiary referral centers (nine in the Czech Republic, one in Slovakia). Approximately 443 patients are required to detect a 15% relative decrease in the need for positive pressure ventilation between trial groups. Centers will be randomized to either CPAP or HFNC at each time period, with parental consent obtained before birth. The primary endpoint is the proportion of neonates requiring positive pressure ventilation within the first 10 minutes post-birth.",[54],"Premature; Infant","NOT_YET_RECRUITING","2024-11-08",{"date":58,"type":59},"2024-11-12","ACTUAL",{"date":61,"type":48},"2024-12",{"date":63,"type":48},"2026-09",{"name":5,"class":6}]