[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622002":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":24,"responsibleParty":34,"collaborators":38,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":24,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":24,"maxAge":24,"enrollmentInfo":107,"targetDuration":24,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":24,"overallStatus":117,"whyStopped":24,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":24},{"fullName":5,"class":6},"Jiulongpo No.1 People's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HFOV","ACTIVE_COMPARATOR","HFOV: 1) Mean airway pressure (MAP) and FiO2: titrated via oxygenation-guided lung recruitment maneuvers21-23 to maintain preductal SpO2 target of 89%-94%. 2) Frequency: 12-15 Hz for birth weight (BW)\\\u003C1500g, and 10-12 Hz for BW≥ 1500g. 3) I:E ratio: 1:1 or 1:2 according to recommendations of manufacturers and local habits",[13],"Device: HFOV",{"label":15,"type":10,"description":16,"interventionNames":17},"HFOV+VG","HFOV-VG Group: ①VThf: \\\u003C1000g 1.5-1.8ml\u002Fkg, 1000-1500g 1.8-2.2ml\u002Fkg, \\>1500g, 2.2-2.5ml\u002Fkg; ②Amplitude automatically adjusted by volume guarantee algorithm and the upper limit was set at 15% above the measured value after achieving the target VThf, with the constraint that it must not exceed 20 cm H2O for BW\\\u003C1000g, 25cm H2O for BW 1000-1500g or 25-30 cmH2O for BW\\>1500g; ③If the target VThf is not achieved after the amplitude has reached its upper limit, airway issues (e.g., suctioning) or lung recruitment should be addressed first, rather than overriding the amplitude limit.",[18],"Device: HFOV+VG",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","HFOV: 1) Mean airway pressure (MAP) and FiO2: titrated via oxygenation-guided lung recruitment maneuvers to maintain preductal SpO2 target of 89%-94%. 2) Frequency: 12-15 Hz for birth weight (BW)\\\u003C1500g, and 10-12 Hz for BW≥ 1500g. 3) I:E ratio: 1:1 or 1:2 according to recommendations of manufacturers and local habits",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"HFOV-VG Group: ①VThf: \\\u003C1000g 1.5-1.8ml\u002Fkg, 1000-1500g 1.8-2.2ml\u002Fkg, \\>1500g, 2.2-2.5ml\u002Fkg; ②Amplitude automatically adjusted by volume guarantee algorithm and the upper limit was set at 15% above the measured value after achieving the target VThf, with the constraint that it must not exceed 20 cm H2O for BW\\\u003C1000g, 25cm H2O for BW 1000-1500g or 25-30 cmH2O for BW\\>1500g; ③If the target VThf is not achieved after the amplitude has reached its upper limit, airway issues (e.g., suctioning) or lung recruitment should be addressed first, rather than overriding the amplitude limit",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Yuan Shi, PhD","CONTACT","+86 23 68757731","shiyuan@hospital.cqmu.edu.cn",{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Xingwang Zhu","Director",[39,41,43,45,48,50,52,54,56,58,61,63,65,67,69,71,73,75,77,79,81,83,85,87,89,91,93,95,97],{"name":40,"class":6},"Children's Hospital of Chongqing Medical University",{"name":42,"class":6},"The Affiliated Hospital of Inner Mongolia Medical University",{"name":44,"class":6},"Affiliated Hospital of Jining Medical University",{"name":46,"class":47},"Chongqing Qianjiang Central Hospital","UNKNOWN",{"name":49,"class":6},"First People's Hospital of Chenzhou",{"name":51,"class":6},"Fujian Maternity and Child Health Hospital",{"name":53,"class":47},"Fuling Hospital of Chongqing University",{"name":55,"class":6},"Guangdong Women and Children Hospital",{"name":57,"class":6},"Zhengzhou Children's Hospital, China",{"name":59,"class":60},"Hunan Children's Hospital","OTHER_GOV",{"name":62,"class":6},"Hunan Provincial Maternal and Child Health Care Hospital",{"name":64,"class":6},"Hunan Provincial People's Hospital",{"name":66,"class":6},"Inner Mongolia Maternal and Child Health Care Hospital",{"name":68,"class":6},"Jiangxi Maternal and Child Health Hospital",{"name":70,"class":6},"Kunming Children's Hospital",{"name":72,"class":6},"Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region",{"name":74,"class":47},"Moscow Regional Research Institute of Obstetrics and Gynecology named after Academician V. I. Krasnopolsky",{"name":76,"class":6},"Northwest Women's and Children's Hospital, Xi'an, Shaanxi",{"name":78,"class":47},"People's Hospital of MeiShan",{"name":80,"class":6},"QuanZhou Women and Children's Hospital",{"name":82,"class":47},"Qujing Maternal and Child Hospital",{"name":84,"class":6},"Second Affiliated Hospital of Wenzhou Medical University",{"name":86,"class":6},"Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University",{"name":88,"class":47},"Shanxi Women and Children Hospital",{"name":90,"class":47},"Shenzhen Longhua Maternity and Child Health Care Hospital",{"name":92,"class":6},"Shijiazhuang Obstetrics and Gynecology Hospital",{"name":94,"class":6},"The Third Affiliated Hospital of Guangzhou Medical University",{"name":96,"class":47},"Women and Children's Hospital of Ningbo University",{"name":98,"class":47},"Zhangzhou Affiliated Hospital of Fujian Medical School","100622002","combined-oscillation-volume-guarantee-study-100622002",false,"NCT07377955","Combined Oscillation-Volume guarantEe Study","Combined Volume Guarantee High-Frequency Oscillatory Ventilation (HFOV-VG) Versus Conventional High-Frequency Oscillatory Ventilation (HFOV) on Grade 2 to 3 Bronchopulmonary Dysplasia (BPD) or Death in Preterm Infants \u003C32 Weeks With Respiratory Distress Syndrome (RDS)","Inclusion Criteria:\n\n* Gestational age 24+0\u002F7\\\u003C 320\u002F7 weeks\n* Diagnosis of RDS within 72 hours after birth, requiring endotracheal ventilation for both elective and rescue HFOV\n\nExclusion Criteria:\n\n* Severe birth defects: severe congenital heart disease, diaphragmatic hernia, gastrointestinal malformations, congenital brain developmental abnormalities, congenital pulmonary cysts\n* Uncorrected shock\n* Existence of grade 3-4 IVH before ventilated\n* Other conditions deemed unsuitable for enrollment by neonatologists, including endotracheal intubation performed specifically for the purpose of the INSURE or INRECSURE technique.","ALL",{"count":108,"type":109},348,"ESTIMATED","INTERVENTIONAL",[112],"NA","Respiratory Distress Syndrome (RDS) remains the most common respiratory complication in the early postnatal period among preterm infants born before 32 weeks' gestational age. For this population, implementing lung-protective ventilation strategies is essential to shorten the duration of intubation, reduce the incidence and severity of bronchopulmonary dysplasia (BPD), lower mortality, and improve overall outcomes.\n\nHFOV-VG was first reported in 2015 to be safely applied in neonates. The fundamental principle lies in its ability to stabilize the tidal volume of high-frequency ventilation (VThf), thereby reducing sheer stress from amplitude fluctuations, while simultaneously permitting lower VThf settings to minimize volutrauma.\n\nThis study aims to evaluate whether HFOV+VG is superior to HFOV in reducing the composite outcome of grade 2-3 BPD or death at 36 weeks' post-menstrual age (PMA).",[115,116],"Respiratory Distress Syndrome (& [Hyaline Membrane Disease])","Bronchopulmonary Dysplasia (BPD)","NOT_YET_RECRUITING","2026-01-22",{"date":120,"type":121},"2026-01-30","ACTUAL",{"date":123,"type":109},"2026-02-01",{"date":125,"type":109},"2028-02-01",{"name":36,"class":6}]