[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513089":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":38,"locations":48,"responsibleParty":222,"collaborators":224,"id":227,"slug":228,"hasResults":229,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":229,"sex":235,"minAge":236,"maxAge":237,"enrollmentInfo":238,"targetDuration":25,"studyType":241,"phases":242,"briefSummary":244,"conditions":245,"keywords":249,"overallStatus":51,"whyStopped":25,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":272},{"fullName":5,"class":6},"ONY","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Arm","EXPERIMENTAL","A single dose of Calfactant at 6ml\u002Fkg administered via the Infasurf Aero™ Nebulizer until completion.",[13],"Combination Product: Infasurf Aero™",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Arm","SHAM_COMPARATOR","Low flow respiratory air alone through the InfasurfAero™ Nebulizer until completion.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"COMBINATION_PRODUCT","Infasurf Aero™","A single dose of Calfactant administered by pacifier interface by inhalation via the Infasurf Aero nebulizer at 6ml\u002Fkg.",[15,9],null,[27,31,34],{"name":28,"affiliation":29,"role":30},"Scott Guthrie, MD","Vanderbilt Jackson-Madison, Jackson TN","STUDY_CHAIR",{"name":32,"affiliation":33,"role":30},"Dinushan Kaluarachchi, MD","Unity Point Meriter, Madison WI",{"name":35,"affiliation":36,"role":37},"Jim Cummings, MD","Ony Biotech","STUDY_DIRECTOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":25,"email":43},"Corey Commaroto, RRT","CONTACT","7163614659","ccommaroto@onybiotech.com",{"name":45,"role":41,"phone":46,"phoneExt":25,"email":47},"Dan Swartz, 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Hospital","Jackson","Tennessee","38301",{"type":58,"coordinates":173},[174,175],-88.81395,35.61452,{"lat":175,"lon":174},[178,182,184],{"name":179,"role":41,"phone":180,"phoneExt":25,"email":181},"Laura Choate, BSN","(731) 541-5000","laura.choate@wth.org",{"name":28,"role":183,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"name":185,"role":70,"phone":25,"phoneExt":25,"email":25},"Stacy Slagle, MD",{"facility":187,"status":51,"city":188,"state":189,"zip":190,"country":55,"countryCode":56,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"Utah Valley Hospital","Provo","Utah","84604",{"type":58,"coordinates":192},[193,194],-111.65853,40.23384,{"lat":194,"lon":193},[197,201,203],{"name":198,"role":41,"phone":199,"phoneExt":25,"email":200},"Jennifer Elmont","801-507-7036","Jennifer.Elmont@imail.org",{"name":202,"role":70,"phone":25,"phoneExt":25,"email":25},"Steven Minton, MD",{"name":204,"role":70,"phone":25,"phoneExt":25,"email":25},"Erick Gerday, MD",{"facility":206,"status":51,"city":207,"state":208,"zip":209,"country":55,"countryCode":56,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"Unity Point Meriter","Madison","Wisconsin","53715",{"type":58,"coordinates":211},[212,213],-89.40123,43.07305,{"lat":213,"lon":212},[216,220],{"name":217,"role":41,"phone":218,"phoneExt":25,"email":219},"Shayla Schwingle Study Coordinator","(608) 417-6000","snschwingle@wisc.edu",{"name":221,"role":70,"phone":25,"phoneExt":25,"email":25},"Dinushuan Kaluarachchi, MD",{"type":223,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[225],{"name":226,"class":6},"Avania","100513089","phase-3-infasurfaero-versus-sham-treatment-in-preterm-newborns-with-rds-100513089",false,"NCT05960929","InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS","InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS: A Single-dose, Double-blind, Random Allocation, Sham-control, Clinical Trial","Aero-05","Inclusion Criteria:\n\nInclusion criteria include ALL of the following:\n\n1. Written informed consent obtained by parent or legal representative prior to or after birth\n2. Gestational age at birth ≥ 29 0\u002F7 AND ≤ 35 6\u002F7 weeks\n3. Birthweight ≥ 1,000 AND ≤ 3,500 grams\n4. Age ≥ 1 hour AND ≤ 6 hours\n5. Clinical diagnosis of surfactant-deficient RDS, with EITHER i. a Silverman-Anderson Retraction Score ≥ 5 (in Room Air), OR ii. signs of respiratory distress (tachypnea, retractions, grunting) AND radiographic confirmation\n6. Require CPAP\n7. Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4\n8. If subject is \\>346\u002F7 weeks' gestation a chest radiograph is required\n\nExclusion Criteria:\n\nExclusion criteria are ANY of the following:\n\n1. Surfactant administration prior to randomization\n2. Mechanical ventilation prior to randomization\n3. Major congenital anomaly (suspected or confirmed)\n4. Abnormality of the airway (suspected or confirmed)\n5. Respiratory distress presumed secondary to an etiology other than RDS (e.g., suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemia shock, hypoxic ischemic encephalopathy)\n6. Apgar score \\\u003C 3 at 5 minutes of age\n7. Umbilical cord gas pH \\\u003C7.0 or BD \\> 10\n8. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk","ALL","29 Weeks","36 Weeks",{"count":239,"type":240},220,"ESTIMATED","INTERVENTIONAL",[243],"PHASE3","The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated way and without the need for a breathing tube or interrupting nasal respiratory support.",[246,247,248],"Respiratory Distress Syndrome (Neonatal)","Intubation Complication","Death; Neonatal",[250,251,252,253,254,255,256,257,258,259,260,261,262],"Infasurf","Calfactant","Inhalation","Nebulization","Preterm","InfasurfAero","Respiratory Distress Syndrome","Neonatal","NICU","CPAP","Intubation","Aerosol","CPAP Failure","2025-03-25",{"date":265,"type":266},"2025-03-30","ACTUAL",{"date":268,"type":266},"2025-01-01",{"date":270,"type":240},"2026-04-01",{"name":5,"class":6},10]