[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648729":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":39,"responsibleParty":56,"collaborators":11,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":11,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":11,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":11,"overallStatus":79,"whyStopped":11,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Indonesia University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1 with arm label: Nasal Cannula","EXPERIMENTAL",null,[13],"Device: Experimental, Intervention Name: Nasal Cannula",{"label":15,"type":16,"description":11,"interventionNames":17},"Arm 2 with arm label: Single Nasal Prong","ACTIVE_COMPARATOR",[18],"Device: Active comparator: single nasal prong",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DEVICE","Experimental, Intervention Name: Nasal Cannula","Non-invasive ventilation delivered through a nasal cannula as the respiratory interface for one hour after randomization in preterm infants after birth.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Active comparator: single nasal prong","Non-invasive ventilation delivered through a single nasal prong as the respiratory interface for one hour after randomization in preterm infants after birth.",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Raden Adhi Teguh Perma Iskandar, Principal Investigator","CONTACT","085779153162","adhitpi@gmail.com",{"name":36,"role":32,"phone":37,"phoneExt":11,"email":38},"Ina Rochayati","087712526805","inarochayati@gmail.com",[40],{"facility":41,"status":11,"city":42,"state":43,"zip":11,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Rumah Sakit dr. Cipto Mangunkusumo","Jakarta","DKI Jakarta","Indonesia","ID",{"type":47,"coordinates":48},"Point",[49,50],106.84513,-6.21462,{"lat":50,"lon":49},[53,54],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},{"name":55,"role":32,"phone":37,"phoneExt":11,"email":38},"Rochayati Ina",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Adhi Teguh Perma Iskandar, Sp","Consultant Neonatologist","100648729","nasal-cannula-versus-single-nasal-prong-for-non-invasive-ventilation-in-preterm-infants-100648729",false,"NCT07725614","Nasal Cannula Versus Single Nasal Prong for Non-Invasive Ventilation in Preterm Infants","Nasal Cannula Versus Single Nasal Prong for Non-Invasive Ventilation in Preterm Infants After Birth: A Randomized Controlled Trial","Inclusion Criteria:\n\nInclusion Criteria:\n\n1. Preterm infants with a gestational age of 28 to \\\u003C37 weeks who develop respiratory distress and require non-invasive ventilation (NIV) after birth.\n2. Written informed consent is obtained from a parent or legal guardian.\n\nExclusion Criteria:\n\n1. Infants with congenital nasal defects, including cleft lip and palate.\n2. Infants with prenatally diagnosed congenital anomalies that contraindicate NIV, including congenital diaphragmatic hernia, choanal atresia, esophageal atresia with tracheoesophageal fistula, or congenital heart disease.\n3. Infants with multiple congenital anomalies.\n4. Infants requiring endotracheal intubation for positive pressure ventilation immediately after birth.","ALL","0 Minutes","6 Hours",{"count":71,"type":72},140,"ESTIMATED","INTERVENTIONAL",[75],"NA","Preterm infants frequently require non-invasive ventilation (NIV) to treat respiratory distress after birth. The effectiveness of NIV may be influenced by the interface used to deliver respiratory support. Nasal cannula and single nasal prong are two interfaces commonly used for NIV; however, evidence directly comparing their efficacy during the early postnatal period remains limited.\n\nThis randomized controlled trial aims to compare the efficacy of a nasal cannula and a single nasal prong as interfaces for non-invasive ventilation in preterm infants after birth. Eligible preterm infants requiring NIV after initial stabilization will be randomly assigned to receive respiratory support using either a nasal cannula or a single nasal prong. The assigned interface will be maintained for one hour following randomization, including during transport from the delivery room to the neonatal intensive care unit.\n\nThe primary outcome is the need for endotracheal intubation within one hour after interface application. Secondary outcomes include the need for endotracheal intubation within 6 hour of age, respiratory effectiveness, assessed by the oxygen saturation index (OSI) and arterial blood gas parameters (pH and partial pressure of carbon dioxide \\[pCO₂\\]), as well as interface-related adverse events, including interface dislodgement and nasal injury.\n\nThis study is expected to provide evidence to support the selection of an effective non-invasive ventilation interface for preterm infants after birth.",[78],"Prematurity","NOT_YET_RECRUITING","2026-07-21",{"date":82,"type":83},"2026-07-24","ACTUAL",{"date":85,"type":72},"2026-07-20",{"date":87,"type":72},"2027-07-20",{"name":5,"class":6},1]