Combined Oscillation-Volume guarantEe Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorXingwang Zhu

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • HFOV
  • HFOV+VG

Treatment groups

348 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

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