400
Participants
Start Date
October 1, 2025
Primary Completion Date
June 30, 2028
Study Completion Date
December 31, 2028
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).~Crossover 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."
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.~Crossover 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.~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/or transcutaneous monitoring in both groups."
RECRUITING
Children's Hospital of Chongqing Medical University, Chongqing
Collaborators (1)
Children's Hospital of Chongqing Medical University
OTHER
Jiulongpo No.1 People's Hospital
OTHER
Chongqing Maternal and Child Health Hospital
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
Children's Hospital of The Capital Institute of Pediatrics
OTHER
Peking University Third Hospital
OTHER
First Hospital of Tsinghua University
OTHER
Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital
OTHER
First Affiliated Hospital of Chongqing Medical University
OTHER
Quanzhou Children's Hospital
OTHER
Xiamen Maternity & Child Care Hospital
OTHER
Zhujiang Hospital
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Guangdong Academy of Medical Science and General Hospital
OTHER
Guangdong Women and Children Hospital
OTHER
Women and Children's Health Hospital of Yulin
OTHER
Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
OTHER
Second Affiliated Hospital of Guangzhou Medical University
OTHER
Guiyang Maternal and Child Health Care Hospital
OTHER
The First People's Hospital of Zunyi
OTHER
Lanzhou University Second Hospital
OTHER
Gansu Provincial Maternal and Child Health Care Hospital
OTHER
LanZhou University
OTHER
First Affiliated Hospital of Harbin Medical University
OTHER
First Affiliated Hospital of Xinjiang Medical University
OTHER
Zhengzhou Children's Hospital, China
OTHER
Third Affiliated Hospital of Zhengzhou University
OTHER
the Maternal and Child Health Hospital of Hainan Province
OTHER
Bethune International Peace Hospital
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Children's Hospital of Nanjing Medical University
OTHER
The First Hospital of Jilin University
OTHER
Children's Hospital of Fudan University
OTHER
Maternal and Children's Healthcare Hospital of Taian
OTHER
The Second Hospital of Shandong University
OTHER
Shanxi Provincial Maternity and Children's Hospital
OTHER
Chengdu Women and Children's Center Hospital
OTHER
The Affiliated Hospital Of Southwest Medical University
OTHER
Affiliated Hospital of Southwest Medical University
OTHER
Shenzhen People's Hospital, The Second Medical College of Jinan University
OTHER
Tianjin Central Hospital of Gynecology Obstetrics
OTHER
People's Hospital of Xinjiang Uygur Autonomous Region
OTHER
Kunming Children's Hospital
OTHER
The First People's Hospital of Yunnan
OTHER
First Affiliated Hospital of Kunming Medical University
OTHER
Yan'an Affiliated Hospital of Kunming Medical University
OTHER
Women and Children's Health Hospital of Qujing
OTHER
The People's Hospital of Dehong Autonomous Prefecture
OTHER
The First People's Hospital of Yinchuan
OTHER
The Children's Hospital of Zhejiang University School of Medicine
OTHER
Women's Hospital School Of Medicine Zhejiang University
OTHER
Beijing 302 Hospital
OTHER
Hunan Children's Hospital
OTHER_GOV
Women and Children Hospital of Qinghai Province
OTHER
Jiangxi Province Children's Hospital
OTHER
Inner Mongolia People's Hospital
OTHER
Mianyang Central Hospital
OTHER
People's Liberation Army No.202 Hospital
OTHER
Ningbo Women & Children's Hospital
OTHER
Shanghai Children's Medical Center
OTHER
First Affiliated Hospital of Guangxi Medical University
OTHER
Nanjing Medical University
OTHER
Xianyang Children's Hospital
OTHER
Qinhuangdao Maternal and Child Health Care Hospital
OTHER
Xuzhou Children Hospital
OTHER
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
OTHER