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).
Gestational age 24+0/7< 320/7 weeks
Diagnosis of RDS within 72 hours after birth, requiring endotracheal ventilation for both elective and rescue HFOV
Severe birth defects: severe congenital heart disease, diaphragmatic hernia, gastrointestinal malformations, congenital brain developmental abnormalities, congenital pulmonary cysts
Uncorrected shock
Existence of grade 3-4 IVH before ventilated
Other conditions deemed unsuitable for enrollment by neonatologists, including endotracheal intubation performed specifically for the purpose of the INSURE or INRECSURE technique.
Parallel
HFOV
DeviceHFOV: 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)\<1500g, and 10-12 Hz for BW≥ 1500g. 3) I:E ratio: 1:1 or 1:2 according to recommendations of manufacturers and local habits
HFOV+VG
DeviceHFOV-VG Group: ①VThf: \<1000g 1.5-1.8ml/kg, 1000-1500g 1.8-2.2ml/kg, \>1500g, 2.2-2.5ml/kg; 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\<1000g, 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
Composite outcome of grade 2-3 BPD or in-hospital death at 36 weeks' PMA
In-hospital death at 36 weeks' PMA
The incidence of BPD at 36 weeks' PMA
The duration of invasive ventilation at the time of the first successful extubation
Surfactant doses
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Xingwang Zhu
Lead sponsor
Jiulongpo No.1 People's Hospital
Sponsor institution
Children's Hospital of Chongqing Medical University
Collaborator
The Affiliated Hospital of Inner Mongolia Medical University
Collaborator
Affiliated Hospital of Jining Medical University
Collaborator
Chongqing Qianjiang Central Hospital
Collaborator
First People's Hospital of Chenzhou
Collaborator
Fujian Maternity and Child Health Hospital
Collaborator
Fuling Hospital of Chongqing University
Collaborator
Guangdong Women and Children Hospital
Collaborator
Zhengzhou Children's Hospital, China
Collaborator
Hunan Children's Hospital
Collaborator
Hunan Provincial Maternal and Child Health Care Hospital
Collaborator
Hunan Provincial People's Hospital
Collaborator
Inner Mongolia Maternal and Child Health Care Hospital
Collaborator
Jiangxi Maternal and Child Health Hospital
Collaborator
Kunming Children's Hospital
Collaborator
Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
Collaborator
Moscow Regional Research Institute of Obstetrics and Gynecology named after Academician V. I. Krasnopolsky
Collaborator
Northwest Women's and Children's Hospital, Xi'an, Shaanxi
Collaborator
People's Hospital of MeiShan
Collaborator
QuanZhou Women and Children's Hospital
Collaborator
Qujing Maternal and Child Hospital
Collaborator
Second Affiliated Hospital of Wenzhou Medical University
Collaborator
Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University
Collaborator
Shanxi Women and Children Hospital
Collaborator
Shenzhen Longhua Maternity and Child Health Care Hospital
Collaborator
Shijiazhuang Obstetrics and Gynecology Hospital
Collaborator
The Third Affiliated Hospital of Guangzhou Medical University
Collaborator
Women and Children's Hospital of Ningbo University
Collaborator
Zhangzhou Affiliated Hospital of Fujian Medical School
Collaborator
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