Combined Oscillation-Volume guarantEe Study

Summary

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).

Conditions

• Respiratory Distress Syndrome (& [Hyaline Membrane Disease])
• Bronchopulmonary Dysplasia (BPD)

Interventions

DEVICE

HFOV+VG

HFOV-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

DEVICE

HFOV

HFOV: 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

Sponsors & Collaborators

• Children's Hospital of Chongqing Medical University

  collaborator OTHER

• The Affiliated Hospital of Inner Mongolia Medical University

  collaborator OTHER

• The Affiliated Hospital of Jining Medical University and Zaozhuang City

  collaborator UNKNOWN

• Chongqing Qianjiang Central Hospital

  collaborator UNKNOWN

• First People's Hospital of Chenzhou

  collaborator OTHER

• Fujian Children's Hospital

  collaborator UNKNOWN

• Fuling Hospital of Chongqing University

  collaborator UNKNOWN

• Guangdong Women and Children Hospital

  collaborator OTHER

• Henan Children's Hospital Zhengzhou Children's Hospital

  collaborator UNKNOWN

• Hunan Children's Hospital

  collaborator OTHER_GOV

• Hunan Provincial Maternal and Child Health Care Hospital

  collaborator OTHER

• Hunan Provincial People's Hospital

  collaborator OTHER

• Inner Mongolia Maternal and Child Health Care Hospital

  collaborator OTHER

• Jiangxi Maternal and Child Health Hospital

  collaborator OTHER

• Kunming Children's Hospital

  collaborator OTHER

• Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region

  collaborator OTHER

• Moscow Regional Research Institute of Obstetrics and Gynecology named after Academician V. I. Krasnopolsky

  collaborator UNKNOWN

• Northwest Women's and Children's Hospital, Xi'an, Shaanxi

  collaborator OTHER

• People's Hospital of MeiShan

  collaborator UNKNOWN

• Quanzhou Women's and Children's Hospital

  collaborator UNKNOWN

• Qujing Maternal and Child Hospital

  collaborator UNKNOWN

• Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

  collaborator UNKNOWN

• Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University

  collaborator UNKNOWN

• Shanxi Women and Children Hospital

  collaborator UNKNOWN

• Shenzhen Longhua Maternity and Child Health Care Hospital

  collaborator UNKNOWN

• Shijiazhuang Obstetrics and and Gynecology Hospital

  collaborator UNKNOWN

• Third Affiliated Hospital of Guangzhou Medical University

  collaborator UNKNOWN

• Women and Children's Hospital of Chongqing Medical University

  collaborator UNKNOWN

• Women and Children's Hospital of Ningbo University

  collaborator UNKNOWN

• Zhangzhou Affiliated Hospital of Fujian Medical School

  collaborator UNKNOWN

• Xingwang Zhu

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-01

Primary Completion

2028-02-01

Completion

2028-02-01