[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100342291":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":53,"collaborators":57,"id":188,"slug":189,"hasResults":190,"nctId":191,"briefTitle":192,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":190,"sex":195,"minAge":196,"maxAge":197,"enrollmentInfo":198,"targetDuration":26,"studyType":201,"phases":202,"briefSummary":204,"conditions":205,"keywords":26,"overallStatus":34,"whyStopped":26,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":219},{"fullName":5,"class":6},"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"high frenquency oscillation ventilation (HFOV)","EXPERIMENTAL","HFOV + volume guarantee (VG) as the intervention group HFOV was provided only with piston or membrane oscillators capable of delivering true oscillatory pressure with an active expiratory phase (i.e., Acutronic FABIAN-III, SLE 5000, Löwenstein Med LEONI+, or Sensormedics 3100A). Other machines offering high frequency ventilation were excluded. The lung recruitment maneuver was performed as previously described,15 and lung volume was assessed by chest radiography or lung ultrasound, targeting the right diaphragm at the level of 8th-9th rib (or 7th-8th rib in case of air leak).\n\nCrossover between HFOV and CMV This study allowed infants who failed to respond to their assigned ventilation mode to receive a trial of the alternate mode. Crossover criteria for HFOV-assigned neonates included failure for 3 hours to maintain SpO2 ≥ 50% despite FiO2 of 1.0, PaCO2 \\> 60 mmHg for 3 hours, or signs of ventilator-induced cardiac output reduction. Non-responders to HFOV were switched to CMV.",[13],"Device: HFOV",{"label":15,"type":16,"description":17,"interventionNames":18},"conventional mechanical ventilation (CMV)","ACTIVE_COMPARATOR","CMV was delivered by time-cycled, pressure-limited ventilators. Only pressure regulated volume control (PRVC) will be provided by any type of neonatal ventilator.\n\nCrossover criteria for CMV-assigned neonates included failure for 3 hours to maintain SpO2 ≥ 50% despite FiO2 of 1.0, PaCO2 \\> 60 mmHg for 3 hours, or requiring \\> 30 cm H2O PIP to sustain ventilation. Non-responders to CMV were switched to HFOV.\n\nin both groups, ventilator settings were adjusted at the discretion of the attending clinician to maintain a SpO2 between 90%-94%, a PaO2 between 50 and 80 mm Hg and a PaCO2 between 35 and 60 mm Hg and a pH between 7.20 and 7.45. PO2 and PCO2 levels were monitored using arterial blood gas analysis and\u002For transcutaneous monitoring.",[19],"Device: CMV",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","HFOV","HFOV + volume guarantee (VG) as the intervention group HFOV was provided only with piston or membrane oscillators capable of delivering true oscillatory pressure with an active expiratory phase (i.e., Acutronic FABIAN-III, SLE 5000, Löwenstein Med LEONI+, or Sensormedics 3100A). Other machines offering high frequency ventilation were excluded. The lung recruitment maneuver was performed as previously described, and lung volume was assessed by chest radiography or lung ultrasound, targeting the right diaphragm at the level of 8th-9th rib (or 7th-8th rib in case of air leak).\n\nCrossover between HFOV and CMV This study allowed infants who failed to respond to their assigned ventilation mode to receive a trial of the alternate mode. Crossover criteria for HFOV-assigned neonates included failure for 3 hours to maintain SpO2 ≥ 50% despite FiO2 of 1.0, PaCO2 \\> 60 mmHg for 3 hours, or signs of ventilator-induced cardiac output reduction. Non-responders to HFOV were switched to CMV.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"CMV","CMV as the standard group CMV was delivered by time-cycled, pressure-limited ventilators. Only pressure regulated volume control (PRVC) will be provided by any type of neonatal ventilator.\n\nCrossover criteria for CMV-assigned neonates included failure for 3 hours to maintain SpO2 ≥ 50% despite FiO2 of 1.0, PaCO2 \\> 60 mmHg for 3 hours, or requiring \\> 30 cm H2O PIP to sustain ventilation. Non-responders to CMV were switched to HFOV.\n\nVentilator settings were adjusted at the discretion of the attending clinician to maintain a SpO2 between 90%-94%, a PaO2 between 50 and 80 mm Hg and a PaCO2 between 35 and 60 mm Hg and a pH between 7.20 and 7.45. PO2 and PCO2 levels were monitored using arterial blood gas analysis and\u002For transcutaneous monitoring in both groups.",[15],[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Children's Hospital of Chongqing Medical University","RECRUITING","Chongqing","Chongqing Municipality","400042","China","CN",{"type":41,"coordinates":42},"Point",[43,44],106.55771,29.56026,{"lat":44,"lon":43},[47],{"name":48,"role":49,"phone":50,"phoneExt":51,"email":52},"Shi Yuan, PhD,MD","CONTACT","13508300283","86","petshi530@vip.163.com",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":33,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Chen Long,MD","Principal Investigator",[58,59,61,63,65,67,69,71,73,75,77,79,81,83,85,87,89,91,93,95,97,99,101,103,105,107,109,111,113,115,117,119,121,123,125,127,129,131,133,135,137,139,141,143,145,147,149,151,153,155,157,159,161,164,166,168,170,172,174,176,178,180,182,184,186],{"name":33,"class":6},{"name":60,"class":6},"Jiulongpo No.1 People's Hospital",{"name":62,"class":6},"Chongqing Maternal and Child Health Hospital",{"name":64,"class":6},"The First Affiliated Hospital of Anhui Medical University",{"name":66,"class":6},"Children's Hospital of The Capital Institute of Pediatrics",{"name":68,"class":6},"Peking University Third Hospital",{"name":70,"class":6},"First Hospital of Tsinghua University",{"name":72,"class":6},"Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital",{"name":74,"class":6},"First Affiliated Hospital of Chongqing Medical University",{"name":76,"class":6},"Quanzhou Children's Hospital",{"name":78,"class":6},"Xiamen Maternity & Child Care Hospital",{"name":80,"class":6},"Zhujiang Hospital",{"name":82,"class":6},"Nanfang Hospital, Southern Medical University",{"name":84,"class":6},"Guangdong Academy of Medical Science and General Hospital",{"name":86,"class":6},"Guangdong Women and Children Hospital",{"name":88,"class":6},"Women and Children's Health Hospital of Yulin",{"name":90,"class":6},"Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region",{"name":92,"class":6},"Second Affiliated Hospital of Guangzhou Medical University",{"name":94,"class":6},"Guiyang Maternal and Child Health Care Hospital",{"name":96,"class":6},"The First People's Hospital of Zunyi",{"name":98,"class":6},"Lanzhou University Second Hospital",{"name":100,"class":6},"Gansu Provincial Maternal and Child Health Care Hospital",{"name":102,"class":6},"LanZhou University",{"name":104,"class":6},"First Affiliated Hospital of Harbin Medical University",{"name":106,"class":6},"First Affiliated Hospital of Xinjiang Medical University",{"name":108,"class":6},"Zhengzhou Children's Hospital, China",{"name":110,"class":6},"Third Affiliated Hospital of Zhengzhou University",{"name":112,"class":6},"the Maternal and Child Health Hospital of Hainan Province",{"name":114,"class":6},"Bethune International Peace Hospital",{"name":116,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"name":118,"class":6},"Children's Hospital of Nanjing Medical University",{"name":120,"class":6},"The First Hospital of Jilin University",{"name":122,"class":6},"Children's Hospital of Fudan University",{"name":124,"class":6},"Maternal and Children's Healthcare Hospital of Taian",{"name":126,"class":6},"The Second Hospital of Shandong University",{"name":128,"class":6},"Shanxi Provincial Maternity and Children's Hospital",{"name":130,"class":6},"Chengdu Women and Children's Center Hospital",{"name":132,"class":6},"The Affiliated Hospital Of Southwest Medical University",{"name":134,"class":6},"Affiliated Hospital of Southwest Medical University",{"name":136,"class":6},"Shenzhen People's Hospital, The Second Medical College of Jinan University",{"name":138,"class":6},"Tianjin Central Hospital of Gynecology Obstetrics",{"name":140,"class":6},"People's Hospital of Xinjiang Uygur Autonomous Region",{"name":142,"class":6},"Kunming Children's Hospital",{"name":144,"class":6},"The First People's Hospital of Yunnan",{"name":146,"class":6},"First Affiliated Hospital of Kunming Medical University",{"name":148,"class":6},"Yan'an Affiliated Hospital of Kunming Medical University",{"name":150,"class":6},"Women and Children's Health Hospital of Qujing",{"name":152,"class":6},"The People's Hospital of Dehong Autonomous Prefecture",{"name":154,"class":6},"The First People's Hospital of Yinchuan",{"name":156,"class":6},"The Children's Hospital of Zhejiang University School of Medicine",{"name":158,"class":6},"Women's Hospital School Of Medicine Zhejiang University",{"name":160,"class":6},"Beijing 302 Hospital",{"name":162,"class":163},"Hunan Children's Hospital","OTHER_GOV",{"name":165,"class":6},"Women and Children Hospital of Qinghai Province",{"name":167,"class":6},"Jiangxi Province Children's Hospital",{"name":169,"class":6},"Inner Mongolia People's Hospital",{"name":171,"class":6},"Mianyang Central Hospital",{"name":173,"class":6},"People's Liberation Army No.202 Hospital",{"name":175,"class":6},"Ningbo Women & Children's Hospital",{"name":177,"class":6},"Shanghai Children's Medical Center",{"name":179,"class":6},"First Affiliated Hospital of Guangxi Medical University",{"name":181,"class":6},"Nanjing Medical University",{"name":183,"class":6},"Xianyang Children's Hospital",{"name":185,"class":6},"Qinhuangdao Maternal and Child Health Care Hospital",{"name":187,"class":6},"Xuzhou Children Hospital","100342291","high-frequency-oscillation-ventilation-versus-conventional-mechanical-ventilation-in-very-preterm-infants-with-perinatal-acute-respiratory-distress-syndrome-multicenters-randomized-controlled-superiority-trial-100342291",false,"NCT03736707","High-Frequency Oscillation Ventilation Versus Conventional Mechanical Ventilation in Very Preterm Infants With Perinatal Acute Respiratory Distress Syndrome: Multicenters Randomized Controlled, Superiority Trial","HFOV for ARDS","Inclusion criteria\n\n1. GA was between 24+0 and 31+6 weeks.\n2. Preterm neonates were admitted to NICU within 1 hours after birth, diagnosed with perinatal ARDS using Montreux guidelines and stable supported by CMV.\n3. Stabilization for 2 hours before randomization: FiO2 0.40, mean airway pressure (MAP) 10-14 cmH2O, ≤ 40 bpm of respiratory rate, 90%-94% of SpO2, pH \\> 7.20, PaCO2 60 mmHg, tidal volume of 5 ml\u002Fkg and \\> 35% of hematocrit (these may be evaluated by arterial blood gas analysis).\n\nExclusion criteria\n\nNeonates were not included if any of the following criteria were met:\n\n1. Parents or guardians' decision not to participate.\n2. Major congenital anomalies or chromosomal abnormalities\n3. Need for surgery or more than grade 2nd of IVH before randomization.","ALL","1 Minute","1 Hour",{"count":199,"type":200},400,"ESTIMATED","INTERVENTIONAL",[203],"NA","Bronchopulmonary dysplasia (BPD) is a complex disorder and remains the most common complication in very preterm infants. Its incidence is increased with gestational age from 95.5% among infants born at 22 weeks' gestation to 22.2% among those born at 29 weeks' gestation. BPD is associated with the increased risks of delayed neurodevelopment and pulmonary impairment. High incidences of BPD and morbidities indicate inadequacy of current management guidelines of BPD.3 Caffeine reduces the development of BPD by lowering the duration of intubation.4 How to further reduce the risk of BPD and the duration of invasive ventilation remain the key focus for neonatologists.",[206,207,208,209],"Acute Respiratory Distress Syndrome","High Frequency Oscillatory Ventilation","Preterm","Conventional Mechanical Ventilation","2025-09-30",{"date":212,"type":213},"2025-10-06","ACTUAL",{"date":215,"type":200},"2025-10-01",{"date":217,"type":200},"2028-12-31",{"name":5,"class":6},1]