[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633032":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":29,"centralContacts":36,"locations":42,"responsibleParty":53,"collaborators":29,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":29,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":86,"whyStopped":29,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Istanbul University - Cerrahpasa","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Binasal Prong","EXPERIMENTAL","Preterm infants receiving non-invasive ventilation support via binasal prong interface.",[13],"Device: Binasal Prong",{"label":15,"type":10,"description":16,"interventionNames":17},"Nasal Cannula","Preterm infants receiving non-invasive ventilation support via nasal cannula interface.",[18],"Device: Nasal Cannula",{"label":20,"type":10,"description":21,"interventionNames":22},"Nasal Mask","Preterm infants receiving non-invasive ventilation support via nasal mask interface.",[23],"Device: Nasal Mask",[25,30,33],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","Continuous positive airway pressure (CPAP) delivered via binasal prong interface.",[9],null,{"type":26,"name":15,"description":31,"armGroupLabels":32,"otherNames":29},"Continuous positive airway pressure (CPAP) delivered via nasal cannula.",[15],{"type":26,"name":20,"description":34,"armGroupLabels":35,"otherNames":29},"Continuous positive airway pressure (CPAP) delivered via nasal mask interface.",[20],[37],{"name":38,"role":39,"phone":40,"phoneExt":29,"email":41},"Esra CUMUR BAŞKIR","CONTACT","+90 541 680 21 59","cumuresra@ogr.iuc.edu.tr",[43],{"facility":44,"status":29,"city":45,"state":29,"zip":29,"country":46,"countryCode":29,"cosmosGeoPoint":47,"geoPoint":52,"contacts":29},"Tekirdag Ismail Fehmi Cumalioglu City Hospital, Neonatal Intensive Care Unit","Tekirdağ","Turkey (Türkiye)",{"type":48,"coordinates":49},"Point",[50,51],27.51101,40.9781,{"lat":51,"lon":50},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Esra Cumur Baskir","Principal Investigator","100633032","non-invasive-ventilation-interfaces-and-nasal-pressure-injury-in-preterm-infants-100633032",false,"NCT07521410","Non-Invasive Ventilation Interfaces and Nasal Pressure Injury in Preterm Infants","Comparison of the Effects of Different Non-Invasive Ventilation Interfaces on the Development of Medical Device-Related Nasal Pressure Injury in Preterm Infants","NIV-MDRPI","Inclusion Criteria:\n\n* Preterm infants with a gestational age between 28 and 37 weeks\n* Receiving non-invasive ventilation support in a neonatal intensive care unit\n* Receiving non-invasive ventilation for at least 4 days\n* Parental consent obtained\n\nExclusion Criteria:\n\n* Infants requiring intubation\n* Presence of congenital anomalies\n* Pre-existing nasal injury or trauma\n* Presence of skin disease\n* Nasal lesions due to previous nasotracheal intubation\n* Upper airway malformations\n* Infants transferred from another center after receiving more than 24 hours of non-invasive ventilation","ALL","0 Minutes","28 Days",{"count":69,"type":70},75,"ESTIMATED","INTERVENTIONAL",[73],"NA","The goal of this randomized controlled clinical trial is to learn whether different non-invasive ventilation interfaces can prevent medical device-related nasal pressure injury in preterm infants receiving respiratory support in a neonatal intensive care unit.\n\nThe main questions it aims to answer are:\n\n* Do different non-invasive ventilation interfaces affect how often nasal pressure injury develops?\n* Do these interfaces affect the severity of nasal pressure injury and the condition of the nasal skin?\n\nResearchers will compare three types of non-invasive ventilation interfaces (binasal prong, nasal cannula, and nasal mask) to see if one method is more effective in reducing nasal pressure injury.\n\nParticipants will:\n\n* Be randomly assigned to one of three groups (binasal prong, nasal cannula, or nasal mask)\n* Receive non-invasive ventilation support using the assigned interface for at least 4 days\n* Have their nasal skin assessed every 12 hours for 96 hours using standardized scales\n* Continue to receive routine care in the neonatal intensive care unit",[76,77],"Medical Device-Related Pressure Injury","Prematurity",[79,80,81,82,83,84,85],"Preterm infants","Non-invasive ventilation","Nasal pressure injury","Medical device-related pressure injury","Neonatal intensive care unit","CPAP","Nasal interface","NOT_YET_RECRUITING","2026-04-13",{"date":89,"type":90},"2026-04-16","ACTUAL",{"date":92,"type":70},"2026-04-20",{"date":94,"type":70},"2026-10-24",{"name":5,"class":6},1]