High-Frequency Oscillation Ventilation Versus Conventional Mechanical Ventilation in Very Preterm Infants With Perinatal Acute Respiratory Distress Syndrome: Multicenters Randomized Controlled, Superiority Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: Newborn
Healthy Volunteers: f
View:
• GA was between 24+0 and 31+6 weeks.
• Preterm neonates were admitted to NICU within 1 hours after birth, diagnosed with perinatal ARDS using Montreux guidelines and stable supported by CMV.
• 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/kg and \> 35% of hematocrit (these may be evaluated by arterial blood gas analysis).
Locations
Other Locations
China
Children's Hospital of Chongqing Medical University
RECRUITING
Chongqing
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 400
Treatments
Experimental: high frenquency oscillation ventilation (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,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).~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.
Active_comparator: conventional mechanical ventilation (CMV)
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.~in 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/or transcutaneous monitoring.
Related Therapeutic Areas
Sponsors
Collaborators: Maternal and Children's Healthcare Hospital of Taian, Inner Mongolia People's Hospital, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Women's Hospital School Of Medicine Zhejiang University, the Maternal and Child Health Hospital of Hainan Province, Women and Children Hospital of Qinghai Province, First Affiliated Hospital of Xinjiang Medical University, Gansu Provincial Maternal and Child Health Care Hospital, The Affiliated Hospital Of Southwest Medical University, Peking University Third Hospital, Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital, First Affiliated Hospital of Harbin Medical University, The First Hospital of Jilin University, First Hospital of Tsinghua University, Beijing 302 Hospital, Qinhuangdao Maternal and Child Health Care Hospital, Affiliated Hospital of Southwest Medical University, Guangdong Women and Children Hospital, The Second Hospital of Shandong University, Chengdu Women and Children's Center Hospital, Shenzhen People's Hospital, The Second Medical College of Jinan University, Children's Hospital of Nanjing Medical University, Ningbo Women & Children's Hospital, The First People's Hospital of Zunyi, People's Liberation Army No.202 Hospital, Children's Hospital of Fudan University, Jiulongpo No.1 People's Hospital, Second Affiliated Hospital of Guangzhou Medical University, Nanjing Medical University, Tianjin Central Hospital of Gynecology Obstetrics, First Affiliated Hospital of Chongqing Medical University, Kunming Children's Hospital, Yan'an Affiliated Hospital of Kunming Medical University, Xiamen Maternity & Child Care Hospital, Bethune International Peace Hospital, Children's Hospital of The Capital Institute of Pediatrics, The Children's Hospital of Zhejiang University School of Medicine, First Affiliated Hospital of Guangxi Medical University, People's Hospital of Xinjiang Uygur Autonomous Region, Women and Children's Health Hospital of Qujing, Children's Hospital of Chongqing Medical University, Hunan Children's Hospital, First Affiliated Hospital of Kunming Medical University, Mianyang Central Hospital, Xianyang Children's Hospital, Nanfang Hospital, Southern Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shanxi Provincial Maternity and Children's Hospital, Women and Children's Health Hospital of Yulin, Chongqing Maternal and Child Health Hospital, Lanzhou University Second Hospital, Zhujiang Hospital, Guangdong Academy of Medical Science and General Hospital, The People's Hospital of Dehong Autonomous Prefecture, Third Affiliated Hospital of Zhengzhou University, LanZhou University, The First People's Hospital of Yinchuan, The First Affiliated Hospital of Anhui Medical University, Jiangxi Province Children's Hospital, The First People's Hospital of Yunnan, Xuzhou Children Hospital, Guiyang Maternal and Child Health Care Hospital, Shanghai Children's Medical Center, Quanzhou Children's Hospital, Zhengzhou Children's Hospital, China
Leads: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University