[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607084":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":21,"locations":31,"responsibleParty":100,"collaborators":10,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":104,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":10,"studyType":116,"phases":10,"briefSummary":117,"conditions":118,"keywords":123,"overallStatus":129,"whyStopped":10,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Muğla Sıtkı Koçman University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Infants >28 weeks GA treated with NIPPV due to respiratory distress within the first 12 h of life",null,"Infants born at \\>28 weeks of gestation who develop respiratory distress within the first 6 h of life and receive noninvasive ventilation therapy (NIPPV) within the first 12 h will be included in the study. Silverman-Andersen and Downes scores will be assessed 20-30 minutes after initiation of NIPPV using standardized scoring systems. Blood gas analysis will be performed within 30 minutes after NIPPV initiation. Additional indices of respiratory severity-including the respiratory severity score (RSS), FiO₂, mean airway pressure (MAP), and oxygen saturation index (OSI)-will be recorded at 20-30 minutes. RSS will be calculated as FiO₂ × MAP; MAP as \\[(Ti × PIP) + (Te × PEEP)\\] \u002F (Ti + Te); and OSI as \\[MAP (cmH₂O) × FiO₂ (%)\\] \u002F SpO₂ (%)\\] (18, 19). NIPPV failure will be defined as the need for intubation in an infant receiving NIPPV. In the same infants, the predictive value of the Silverman-Andersen score and the Downes score for NIPPV failure at 24 hours and 72 hours will be evaluated.",[13,17],{"name":14,"affiliation":15,"role":16},"Ozkan Ilhan","Mugla Training and Research Hospital","STUDY_DIRECTOR",{"name":18,"affiliation":19,"role":20},"Ozkan Ilhan, Assoc. Prof.","Mugla Sitki Kocman University School of Medicine","PRINCIPAL_INVESTIGATOR",[22,27],{"name":23,"role":24,"phone":25,"phoneExt":10,"email":26},"Ozkan Ilhan, Associate Professor","CONTACT","+90 506 293 4400","drozkanilhan@gmail.com",{"name":28,"role":24,"phone":29,"phoneExt":10,"email":30},"Ipek Kocaoglu, Dr.","+90 530 516 5187","ipekkc@gmail.com",[32,52,63,83],{"facility":33,"status":10,"city":34,"state":34,"zip":10,"country":35,"countryCode":10,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Akdeniz University School of Medicine, Department of Neonatology","Antalya","Turkey (Türkiye)",{"type":37,"coordinates":38},"Point",[39,40],30.69556,36.90812,{"lat":40,"lon":39},[43,47,49],{"name":44,"role":24,"phone":45,"phoneExt":10,"email":46},"Kiymet Celik, Assoc. Prof.","0 505 495 8494","kiymetcelikmd@gmail.com",{"name":48,"role":20,"phone":10,"phoneExt":10,"email":10},"Kiymet Celik, MD",{"name":50,"role":51,"phone":10,"phoneExt":10,"email":10},"Ayca Celik, MD","SUB_INVESTIGATOR",{"facility":53,"status":10,"city":34,"state":34,"zip":10,"country":35,"countryCode":10,"cosmosGeoPoint":54,"geoPoint":56,"contacts":57},"Antalya Training and Research Hospital, Department of Neonatology",{"type":37,"coordinates":55},[39,40],{"lat":40,"lon":39},[58,62],{"name":59,"role":24,"phone":60,"phoneExt":10,"email":61},"Nurten Ozkan Zarif, MD","+90 554 567 6750","nuurten25@hotmail.com",{"name":59,"role":20,"phone":10,"phoneExt":10,"email":10},{"facility":64,"status":10,"city":65,"state":66,"zip":67,"country":35,"countryCode":10,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Mugla Training and Research Hospital, Department of Neonatology","Muğla","Mentese","48000",{"type":37,"coordinates":69},[70,71],28.3665,37.21807,{"lat":71,"lon":70},[74,75,77,79,81],{"name":18,"role":24,"phone":25,"phoneExt":10,"email":26},{"name":76,"role":51,"phone":10,"phoneExt":10,"email":10},"Candan Sanli, MD",{"name":78,"role":51,"phone":10,"phoneExt":10,"email":10},"Gulshan Humbatova, MD",{"name":80,"role":51,"phone":10,"phoneExt":10,"email":10},"Ipek Kocaoglu, MD",{"name":82,"role":51,"phone":10,"phoneExt":10,"email":10},"Nilay Hakan, Prof. Dr.",{"facility":84,"status":10,"city":85,"state":86,"zip":10,"country":35,"countryCode":10,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Sanliurfa Training and Research Hospital, Department of Neonatology","Sanliurfa","Şanlıurfa",{"type":37,"coordinates":88},[89,90],38.79392,37.16708,{"lat":90,"lon":89},[93,97,98],{"name":94,"role":24,"phone":95,"phoneExt":10,"email":96},"Halil Aslan, MD","0 545 351 8140","drhaslan1@gmail.com",{"name":94,"role":20,"phone":10,"phoneExt":10,"email":10},{"name":99,"role":51,"phone":10,"phoneExt":10,"email":10},"Ihsan Yildirim, MD",{"type":20,"investigatorFullName":14,"investigatorTitle":101,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Associate Professor","100607084","comparison-of-the-silverman-andersen-score-and-the-downes-score-100607084",false,"NCT07183956","Comparison of the Silverman-Andersen Score and the Downes Score","Comparison of the Silverman-Andersen Score and the Downes Score in Assessing the Severity of Respiratory Distress and Predicting Noninvasive Ventilation Failure in Neonates","CSASDS","Inclusion Criteria:\n\n* Preterm infants born at \\>28 weeks of gestation or term infants born at ≥37 weeks of gestation.\n* Development of respiratory distress within the first 6 hours after birth, defined as the presence of at least two of the following: Respiratory rate ≥60\u002Fmin, Subcostal\u002Fintercostal retractions, Grunting.\n* Persistence of respiratory distress for more than 6 hours.\n* Age within the first 12 hours of life.\n* Silverman-Andersen score ≥3.\n* Receiving NIPPV support.\n\nExclusion Criteria:\n\n* Major congenital malformations.\n* Airway or pulmonary anomalies.\n* Cardiovascular or respiratory instability due to sepsis.\n* Cyanotic congenital heart disease.\n* Severe intraventricular hemorrhage.\n* Contraindications for NIPPV therapy (e.g., congenital nasal anomalies, congenital diaphragmatic hernia, abdominal wall defects).\n* Requirement of intubation or chest compressions in the delivery room.\n* Requirement of intubation within the first hour of life.\n* Death within the first 24 hours of life.\n* Gestational age ≤28 weeks.\n* Diagnosis of air leak syndrome (pneumothorax) prior to initiation of NIPPV therapy.","ALL","2 Hours","12 Hours",{"count":114,"type":115},220,"ESTIMATED","OBSERVATIONAL","This study aimed to compare the Silverman-Andersen score and the Downes score in predicting noninvasive ventilation (NIPPV) failure in preterm and term infants who received NIPPV support due to postnatal respiratory distress, as well as to evaluate the agreement of these scoring systems with other methods used to assess the severity of respiratory distress.\n\nThe present study was designed as a prospective, multicenter, observational study conducted with neonates undergoing noninvasive ventilation.",[119,120,121,122],"Respiratory Distress Neonatal","Noninvasive Ventilation","Intubation","Scoring Systems",[124,125,126,127,128],"Silverman-Andersen score","Downes score","Newborn","Respiratory distress","Noninvasive ventilation","NOT_YET_RECRUITING","2025-09-13",{"date":132,"type":133},"2025-09-19","ACTUAL",{"date":135,"type":115},"2025-09-15",{"date":137,"type":115},"2027-02-15",{"name":5,"class":6},4]