Combined Oscillation-Volume guarantEe Study

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. HFOV-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. This 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).

NCT Number	NCT07377955
Lead Sponsor	Xingwang Zhu Collaborators: Children's Hospital of Chongqing Medical University, The Affiliated Hospital of Inner Mongolia Medical University, Affiliated Hospital of Jining Medical University, Chongqing Qianjiang Central Hospital, First People's Hospital of Chenzhou, Fujian Maternity and Child Health Hospital, Fuling Hospital of Chongqing University, Guangdong Women and Children Hospital, Zhengzhou Children's Hospital, China, Hunan Children's Hospital, Hunan Provincial Maternal and Child Health Care Hospital, Hunan Provincial People's Hospital, Inner Mongolia Maternal and Child Health Care Hospital, Jiangxi Maternal and Child Health Hospital, Kunming Children's Hospital, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Moscow Regional Research Institute of Obstetrics and Gynecology named after Academician V. I. Krasnopolsky, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, People's Hospital of MeiShan, QuanZhou Women and Children's Hospital, Qujing Maternal and Child Hospital, Second Affiliated Hospital of Wenzhou Medical University, Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Shanxi Women and Children Hospital, Shenzhen Longhua Maternity and Child Health Care Hospital, Shijiazhuang Obstetrics and Gynecology Hospital, The Third Affiliated Hospital of Guangzhou Medical University, Women and Children's Hospital of Ningbo University, Zhangzhou Affiliated Hospital of Fujian Medical School
Conditions	Respiratory Distress Syndrome (& [Hyaline Membrane Disease]), Bronchopulmonary Dysplasia (BPD)
Enrollment	348 participants
Start Date	2026-02-01
Primary Completion	2028-02-01 (estimated)
Study Completion	2028-02-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-30