High-Frequency Oscillation Ventilation Versus Conventional Mechanical Ventilation in Very Preterm Infants With Perinatal Acute Respiratory Distress Syndrome: Multicenters Randomized Controlled, Superiority Trial

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.

NCT Number	NCT03736707
Lead Sponsor	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Collaborators: Children's Hospital of Chongqing Medical University, Jiulongpo No.1 People's Hospital, Chongqing Maternal and Child Health Hospital, The First Affiliated Hospital of Anhui Medical University, Children's Hospital of The Capital Institute of Pediatrics, Peking University Third Hospital, First Hospital of Tsinghua University, Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital, First Affiliated Hospital of Chongqing Medical University, Quanzhou Children's Hospital, Xiamen Maternity & Child Care Hospital, Zhujiang Hospital, Nanfang Hospital, Southern Medical University, Guangdong Academy of Medical Science and General Hospital, Guangdong Women and Children Hospital, Women and Children's Health Hospital of Yulin, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Second Affiliated Hospital of Guangzhou Medical University, Guiyang Maternal and Child Health Care Hospital, The First People's Hospital of Zunyi, Lanzhou University Second Hospital, Gansu Provincial Maternal and Child Health Care Hospital, LanZhou University, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Xinjiang Medical University, Zhengzhou Children's Hospital, China, Third Affiliated Hospital of Zhengzhou University, the Maternal and Child Health Hospital of Hainan Province, Bethune International Peace Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Children's Hospital of Nanjing Medical University, The First Hospital of Jilin University, Children's Hospital of Fudan University, Maternal and Children's Healthcare Hospital of Taian, The Second Hospital of Shandong University, Shanxi Provincial Maternity and Children's Hospital, Chengdu Women and Children's Center Hospital, The Affiliated Hospital Of Southwest Medical University, Affiliated Hospital of Southwest Medical University, Shenzhen People's Hospital, The Second Medical College of Jinan University, Tianjin Central Hospital of Gynecology Obstetrics, People's Hospital of Xinjiang Uygur Autonomous Region, Kunming Children's Hospital, The First People's Hospital of Yunnan, First Affiliated Hospital of Kunming Medical University, Yan'an Affiliated Hospital of Kunming Medical University, Women and Children's Health Hospital of Qujing, The People's Hospital of Dehong Autonomous Prefecture, The First People's Hospital of Yinchuan, The Children's Hospital of Zhejiang University School of Medicine, Women's Hospital School Of Medicine Zhejiang University, Beijing 302 Hospital, Hunan Children's Hospital, Women and Children Hospital of Qinghai Province, Jiangxi Province Children's Hospital, Inner Mongolia People's Hospital, Mianyang Central Hospital, People's Liberation Army No.202 Hospital, Ningbo Women & Children's Hospital, Shanghai Children's Medical Center, First Affiliated Hospital of Guangxi Medical University, Nanjing Medical University, Xianyang Children's Hospital, Qinhuangdao Maternal and Child Health Care Hospital, Xuzhou Children Hospital
Conditions	Acute Respiratory Distress Syndrome, High Frequency Oscillatory Ventilation, Preterm, Conventional Mechanical Ventilation
Enrollment	400 participants
Start Date	2025-10-01
Primary Completion	2028-06-30 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-10-06