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

Summary

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.

Conditions

• Acute Respiratory Distress Syndrome
• High Frequency Oscillatory Ventilation
• Preterm
• Conventional Mechanical Ventilation

Interventions

DEVICE

HFOV

HFOV + volume guarantee (VG) as the intervention group HFOV was provided only with piston or membrane oscillators capable of delivering true oscillatory pressure with an active expiratory phase (i.e., Acutronic FABIAN-III, SLE 5000, Löwenstein Med LEONI+, or Sensormedics 3100A). Other machines offering high frequency ventilation were excluded. The lung recruitment maneuver was performed as previously described, and lung volume was assessed by chest radiography or lung ultrasound, targeting the right diaphragm at the level of 8th-9th rib (or 7th-8th rib in case of air leak). Crossover between HFOV and CMV This study allowed infants who failed to respond to their assigned ventilation mode to receive a trial of the alternate mode. Crossover criteria for HFOV-assigned neonates included failure for 3 hours to maintain SpO2 ≥ 50% despite FiO2 of 1.0, PaCO2 \> 60 mmHg for 3 hours, or signs of ventilator-induced cardiac output reduction. Non-responders to HFOV were switched to CMV.

DEVICE

CMV

CMV as the standard group CMV was delivered by time-cycled, pressure-limited ventilators. Only pressure regulated volume control (PRVC) will be provided by any type of neonatal ventilator. Crossover criteria for CMV-assigned neonates included failure for 3 hours to maintain SpO2 ≥ 50% despite FiO2 of 1.0, PaCO2 \> 60 mmHg for 3 hours, or requiring \> 30 cm H2O PIP to sustain ventilation. Non-responders to CMV were switched to HFOV. Ventilator settings were adjusted at the discretion of the attending clinician to maintain a SpO2 between 90%-94%, a PaO2 between 50 and 80 mm Hg and a PaCO2 between 35 and 60 mm Hg and a pH between 7.20 and 7.45. PO2 and PCO2 levels were monitored using arterial blood gas analysis and/or transcutaneous monitoring in both groups.

Sponsors & Collaborators

• Children's Hospital of Chongqing Medical University

  collaborator OTHER

• Jiulongpo No.1 People's Hospital

  collaborator OTHER

• Chongqing Maternal and Child Health Hospital

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• Children's Hospital of The Capital Institute of Pediatrics

  collaborator OTHER

• Peking University Third Hospital

  collaborator OTHER

• First Hospital of Tsinghua University

  collaborator OTHER

• Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Quanzhou Children's Hospital

  collaborator OTHER

• Xiamen Maternity & Child Care Hospital

  collaborator OTHER

• Zhujiang Hospital

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• Guangdong Academy of Medical Science and General Hospital

  collaborator OTHER

• Guangdong Women and Children Hospital

  collaborator OTHER

• Women and Children's Health Hospital of Yulin

  collaborator OTHER

• Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region

  collaborator OTHER

• Second Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Guiyang Maternal and Child Health Care Hospital

  collaborator OTHER

• The First People's Hospital of Zunyi

  collaborator OTHER

• Lanzhou University Second Hospital

  collaborator OTHER

• Gansu Provincial Maternal and Child Health Care Hospital

  collaborator OTHER

• LanZhou University

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• Zhengzhou Children's Hospital, China

  collaborator OTHER

• Third Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• the Maternal and Child Health Hospital of Hainan Province

  collaborator OTHER

• Bethune International Peace Hospital

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Children's Hospital of Nanjing Medical University

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Children's Hospital of Fudan University

  collaborator OTHER

• Maternal and Children's Healthcare Hospital of Taian

  collaborator OTHER

• The Second Hospital of Shandong University

  collaborator OTHER

• Shanxi Provincial Maternity and Children's Hospital

  collaborator OTHER

• Chengdu Women and Children's Center Hospital

  collaborator OTHER

• The Affiliated Hospital Of Southwest Medical University

  collaborator OTHER

• Affiliated Hospital of Southwest Medical University

  collaborator OTHER

• Shenzhen People's Hospital, The Second Medical College of Jinan University

  collaborator OTHER

• Tianjin Central Hospital of Gynecology Obstetrics

  collaborator OTHER

• People's Hospital of Xinjiang Uygur Autonomous Region

  collaborator OTHER

• Kunming Children's Hospital

  collaborator OTHER

• The First People's Hospital of Yunnan

  collaborator OTHER

• First Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Yan'an Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Women and Children's Health Hospital of Qujing

  collaborator OTHER

• The People's Hospital of Dehong Autonomous Prefecture

  collaborator OTHER

• The First People's Hospital of Yinchuan

  collaborator OTHER

• The Children's Hospital of Zhejiang University School of Medicine

  collaborator OTHER

• Women's Hospital School Of Medicine Zhejiang University

  collaborator OTHER

• Beijing 302 Hospital

  collaborator OTHER

• Hunan Children's Hospital

  collaborator OTHER_GOV

• Women and Children Hospital of Qinghai Province

  collaborator OTHER

• Jiangxi Province Children's Hospital

  collaborator OTHER

• Inner Mongolia People's Hospital

  collaborator OTHER

• Mianyang Central Hospital

  collaborator OTHER

• People's Liberation Army No.202 Hospital

  collaborator OTHER

• Ningbo Women & Children's Hospital

  collaborator OTHER

• Shanghai Children's Medical Center

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Nanjing Medical University

  collaborator OTHER

• Xianyang Children's Hospital

  collaborator OTHER

• Qinhuangdao Maternal and Child Health Care Hospital

  collaborator OTHER

• Xuzhou Children Hospital

  collaborator OTHER

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

1 Minute

Max Age

1 Hour

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-01

Primary Completion

2028-06-30

Completion

2028-12-31

Countries

• China

Study Locations