[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619853":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":124,"collaborators":25,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":25,"eligibilityCriteria":133,"healthyVolunteers":129,"sex":134,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":25,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":148,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"Uludag University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Poractant alfa (LISA)","ACTIVE_COMPARATOR","Preterm infants with respiratory distress syndrome (RDS) will receive poractant alfa via the Less Invasive Surfactant Administration (LISA) technique while on noninvasive respiratory support.",[13],"Drug: Poractant alfa",{"label":15,"type":10,"description":16,"interventionNames":17},"Calfactant (LISA)","Preterm infants with respiratory distress syndrome (RDS) will receive calfactant via the Less Invasive Surfactant Administration (LISA) technique while on noninvasive respiratory support.",[18],"Drug: Calfactant",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Poractant alfa","Poractant alfa will be administered using the Less Invasive Surfactant Administration (LISA) technique. A thin catheter will be inserted into the trachea under direct laryngoscopic visualization, without the need for endotracheal intubation, while the infant continues to breathe spontaneously on noninvasive respiratory support. Dosing and administration will follow standard clinical guidelines. (200 mg\u002Fkg initial dose, 100 mg\u002Fkg repeat dose)",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Calfactant","Calfactant will be administered using the Less Invasive Surfactant Administration (LISA) technique. A thin catheter will be inserted into the trachea under direct laryngoscopic visualization, without the need for endotracheal intubation, while the infant continues to breathe spontaneously on noninvasive respiratory support. Dosing and administration will follow standard clinical guidelines. (100 mg\u002Fkg initial and repeat dose)",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Salih Çağrı Çakır, Associate professor","CONTACT","+90 533 3453739","salihcagri@uludag.edu.tr",[37,62,80,99,113],{"facility":38,"status":39,"city":40,"state":25,"zip":25,"country":41,"countryCode":25,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Bursa City Hospital","RECRUITING","Bursa","Turkey (Türkiye)",{"type":43,"coordinates":44},"Point",[45,46],29.06013,40.19559,{"lat":46,"lon":45},[49,53,55,58,60],{"name":50,"role":33,"phone":51,"phoneExt":25,"email":52},"Erbu Yarcı, Associate professor","+90 505 729 3482","erbuyarci@yahoo.com",{"name":50,"role":54,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"name":56,"role":57,"phone":25,"phoneExt":25,"email":25},"Bayram Ali Dorum, Associate professor","SUB_INVESTIGATOR",{"name":59,"role":57,"phone":25,"phoneExt":25,"email":25},"Birgül Mutlu, Neonatologist",{"name":61,"role":57,"phone":25,"phoneExt":25,"email":25},"Betül Türen, Pediatrician",{"facility":63,"status":39,"city":40,"state":25,"zip":25,"country":41,"countryCode":25,"cosmosGeoPoint":64,"geoPoint":66,"contacts":67},"Division of Neonatology, Department of Pediatrics, Bursa Uludağ University Faculty of Medicine",{"type":43,"coordinates":65},[45,46],{"lat":46,"lon":45},[68,69,71,73,75,77,79],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},{"name":70,"role":57,"phone":25,"phoneExt":25,"email":25},"Fatma Nirgül Köksal, Professor",{"name":72,"role":57,"phone":25,"phoneExt":25,"email":25},"Hilal Özkan, Professor",{"name":74,"role":57,"phone":25,"phoneExt":25,"email":25},"Cansu Sivrikaya Yıldırım, Neonatologist",{"name":76,"role":57,"phone":25,"phoneExt":25,"email":25},"Funda Aydemir, Pediatrician",{"name":78,"role":57,"phone":25,"phoneExt":25,"email":25},"Enes İn, Pediatrician",{"name":32,"role":54,"phone":25,"phoneExt":25,"email":25},{"facility":81,"status":39,"city":40,"state":25,"zip":25,"country":41,"countryCode":25,"cosmosGeoPoint":82,"geoPoint":84,"contacts":85},"Division of Neonatology, Department of Pediatrics, University of Health Sciences Bursa Yuksek İhtisas Training and Research Hospital",{"type":43,"coordinates":83},[45,46],{"lat":46,"lon":45},[86,90,91,93,95,97],{"name":87,"role":33,"phone":88,"phoneExt":25,"email":89},"İpek Güney Varal, Professor","+90 532 3413389","ipekguneyvaral@gmail.com",{"name":87,"role":54,"phone":25,"phoneExt":25,"email":25},{"name":92,"role":57,"phone":25,"phoneExt":25,"email":25},"Gaffari Tunç, Associate professor",{"name":94,"role":57,"phone":25,"phoneExt":25,"email":25},"Onur Bağcı, Neonatologist",{"name":96,"role":57,"phone":25,"phoneExt":25,"email":25},"Aybüke Yazıcı, Associate professor",{"name":98,"role":57,"phone":25,"phoneExt":25,"email":25},"Ayşe Ören, Pediatrician",{"facility":100,"status":39,"city":40,"state":25,"zip":25,"country":41,"countryCode":25,"cosmosGeoPoint":101,"geoPoint":103,"contacts":104},"Dörtçelik Children's Diseases Hospital",{"type":43,"coordinates":102},[45,46],{"lat":46,"lon":45},[105,109,111],{"name":106,"role":33,"phone":107,"phoneExt":25,"email":108},"Fatma Kocael, Neonatologist","+90 505 678 6875","fatma.irioglu@gmail.com",{"name":110,"role":54,"phone":25,"phoneExt":25,"email":25},"Fatma İrioğlu, Neonatologist",{"name":112,"role":57,"phone":25,"phoneExt":25,"email":25},"Kevser Elmas Üstün, Neonatologist",{"facility":114,"status":39,"city":40,"state":25,"zip":25,"country":41,"countryCode":25,"cosmosGeoPoint":115,"geoPoint":117,"contacts":118},"Medicana Bursa Hospital",{"type":43,"coordinates":116},[45,46],{"lat":46,"lon":45},[119,123],{"name":120,"role":33,"phone":121,"phoneExt":25,"email":122},"Şerif Hamitoğlu","+90 555 5541694","drserif@gmail.com",{"name":120,"role":54,"phone":25,"phoneExt":25,"email":25},{"type":54,"investigatorFullName":125,"investigatorTitle":126,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Salih Çağrı Çakır","Associate professor","100619853","phase-4-calfactant-vs-poractant-alfa-using-a-less-invasive-technique-in-preterm-infants-with-respiratory-distress-syndrome-100619853",false,"NCT07350018","Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress Syndrome","Comparison of the Efficacy of Calfactant and Poractant Alfa Surfactants Administered by a Less Invasive Surfactant Administration Technique in Preterm Infants With Respiratory Distress Syndrome","Inclusion Criteria:\n\n* Born at a participating study center hospital.\n* Gestational age between 24 1\u002F7 and 29 6\u002F7 weeks (\\\u003C30 0\u002F7 weeks).\n* Postnatal age within the first 6 hours of life.\n* Being on non-invasive respiratory support.\n* Presence of clinical and radiological findings consistent with respiratory distress syndrome (RDS).\n* Indication for surfactant therapy defined as a requirement for FiO₂ \\>30% to achieve target oxygen saturation (SpO₂ 90-94%) while receiving noninvasive respiratory support with a minimum pressure of 6 cmH₂O.\n* Written informed consent obtained from a parent or legal guardian.\n\nExclusion Criteria:\n\n* Infants who were intubated for any reason before the decision to administer surfactant.\n* Severe birth asphyxia, defined as the need for advanced resuscitation after birth, 10th minute Apgar score ≤5, and arterial blood gas within the first hour of life showing pH \\\u003C7.0 and base excess (BE) ≤-12.\n* Presence of major congenital anomalies.\n* Respiratory distress due to causes other than respiratory distress syndrome (RDS).\n* Congenital heart disease.\n* Congenital diaphragmatic hernia.\n* Pulmonary hypoplasia.\n* Chromosomal abnormalities.\n* Presence of pneumothorax.\n* Lack of informed consent.\n* Neonatal seizures presence.\n* Postnatal age greater than 6 hours.\n* Infants born outside of gestational weeks 24 1\u002F7 - 29 6\u002F7.\n* Requirement for invasive mechanical ventilation at enrollment.\n* Infants receiving noninvasive respiratory support with an FiO₂ requirement \\\u003C0.30.","ALL","0 Hours","6 Hours",{"count":138,"type":139},234,"ESTIMATED","INTERVENTIONAL",[142],"PHASE4","Respiratory distress syndrome (RDS) is a common cause of respiratory failure in preterm infants and is frequently treated with surfactant therapy. With the increasing use of noninvasive ventilation, less invasive methods of surfactant administration have been developed. In the technique known as Less Invasive Surfactant Administration (LISA), surfactant is delivered into the trachea through a thin catheter, without the need for endotracheal intubation. This approach may reduce lung injury and improve respiratory outcomes in spontaneously breathing preterm infants. This multicenter, prospective, randomized study aims to compare the clinical effectiveness of poractant alfa and calfactant when administered using the LISA technique in preterm infants born at less than 30 weeks' gestation with RDS who are not intubated. The study will evaluate short-term outcomes, including the need for intubation, repeat surfactant administration, and respiratory support during the first 72 hours of life, as well as longer-term outcomes such as bronchopulmonary dysplasia and other neonatal morbidities.",[145,146,147],"Respiratory Distress Syndrome in Premature Infants","Respiratory Distress Syndrome (RDS)","Surfactant",[149,150,22,27,151,152,153],"Respiratory Distress Syndrome","Premature infant","surfactant treatment","Less Invasive Surfactant Administration","LISA","2026-04-27",{"date":156,"type":157},"2026-04-28","ACTUAL",{"date":159,"type":157},"2026-01-20",{"date":161,"type":139},"2027-02-20",{"name":5,"class":6},5]