[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659702":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":37,"studyPopulation":30,"armGroups":38,"interventions":50,"overallOfficials":56,"centralContacts":61,"locations":30,"responsibleParty":67,"collaborators":30,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":30,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":30,"maxAge":79,"enrollmentInfo":80,"targetDuration":30,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":97,"whyStopped":30,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":30},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Treatment failure within 72 hours","Number of infants meeting predefined criteria for treatment failure of the assigned non-invasive respiratory support modality within the first 72 hours.","At 72 hours",[14,17,20,24,27],{"measure":15,"description":16,"timeFrame":12},"Need for mechanical ventilation","Number of infants requiring endotracheal intubation and mechanical ventilation.",{"measure":18,"description":19,"timeFrame":12},"Need for surfactant therapy","Number of infants requiring surfactant administration.",{"measure":21,"description":22,"timeFrame":23},"Duration of respiratory support","Mean duration of non-invasive respiratory support in days.","At 28 days",{"measure":25,"description":26,"timeFrame":23},"Incidence of nasal trauma","Number of infants who develop nasal trauma related to the respiratory support interface.",{"measure":28,"description":29,"timeFrame":23},"Incidence of pneumothorax","Number of infants who develop pneumothorax.",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":36,"maskingDescription":30,"whoMasked":30},"NONE","Respiratory distress syndrome is a major cause of morbidity in preterm infants. Non-invasive respiratory support with nasal continuous positive airway pressure (nCPAP) or high-flow nasal cannula (HFNC) is commonly used to avoid intubation.\n\nThis prospective randomized parallel-group trial will compare treatment failure rates within the first 72 hours between preterm infants receiving nCPAP and those receiving HFNC as initial respiratory support.",[39,45],{"label":40,"type":41,"description":42,"interventionNames":43},"Nasal Continuous Positive Airway Pressure","EXPERIMENTAL","Preterm infants will receive nasal continuous positive airway pressure through an appropriate neonatal interface.",[44],"Device: Non-invasive respiratory support",{"label":46,"type":47,"description":48,"interventionNames":49},"High-Flow Nasal Cannula","ACTIVE_COMPARATOR","Preterm infants will receive heated and humidified high-flow nasal cannula therapy.",[44],[51],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":30},"DEVICE","Non-invasive respiratory support","Non-invasive respiratory support using either nCPAP or high-flow nasal cannula according to group allocation.",[46,40],[57],{"name":58,"affiliation":59,"role":60},"Hekma S Farghaly, prof","Pediatrics Department, Assiut University Hospitals","STUDY_CHAIR",[62],{"name":63,"role":64,"phone":65,"phoneExt":30,"email":66},"Yara S Mahmoud, Resident","CONTACT","+20 11 53798964","Yara.17298705@med.aun.edu.eg",{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Yara Sabry Mahmoud","Resident Physician, Department of Pediatrics","100659702","ncpap-versus-high-flow-nasal-cannula-in-preterm-infants-with-rds-100659702",false,"NCT07869719","nCPAP Versus High-Flow Nasal Cannula in Preterm Infants With RDS","Comparison Between the Use of nCPAP and High-Flow Nasal Cannula in Preterm Infants With Respiratory Distress Syndrome in the NICU","Inclusion Criteria:\n\n* \\- Preterm infants with gestational age 28 to 36 weeks and 6 days\n* Clinical diagnosis of respiratory distress syndrome\n* Spontaneous breathing without immediate need for invasive mechanical ventilation\n* Requirement for non-invasive respiratory support\n* Written informed consent from parent or legal guardian\n\nExclusion Criteria:\n\n* \\- Infants requiring immediate endotracheal intubation and mechanical ventilation\n* Major congenital anomalies affecting the respiratory or cardiovascular systems\n* Congenital diaphragmatic hernia\n* Significant congenital heart disease\n* Severe perinatal asphyxia requiring prolonged resuscitation\n* Severe hemodynamic instability\n* Prolonged mechanical ventilation before enrollment","ALL","28 Days",{"count":81,"type":82},94,"ESTIMATED","INTERVENTIONAL",[85],"NA","This randomized controlled trial aims to compare the efficacy and safety of nasal continuous positive airway pressure versus high-flow nasal cannula as initial non-invasive respiratory support in preterm infants with respiratory distress syndrome.",[88,89],"Respiratory Distress Syndrome","Premature Birth",[91,92,93,94,95,96],"nCPAP","High-flow nasal cannula","Respiratory distress syndrome","NICU","Assiut","Preterm infants","NOT_YET_RECRUITING","2026-10-06",{"date":100,"type":101},"2026-10-09","ACTUAL",{"date":103,"type":82},"2026-10-10",{"date":105,"type":82},"2028-02-25",{"name":5,"class":6}]