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

ConditionsAcute Respiratory Distress SyndromeHigh Frequency Oscillatory VentilationPretermConventional Mechanical Ventilation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-1
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

GA was between 24+0 and 31+6 weeks.

Preterm neonates were admitted to NICU within 1 hours after birth, diagnosed with perinatal ARDS using Montreux guidelines and stable supported by CMV.

Stabilization for 2 hours before randomization: FiO2 0.40, mean airway pressure (MAP) 10-14 cmH2O, ≤ 40 bpm of respiratory rate, 90%-94% of SpO2, pH > 7.20, PaCO2 60 mmHg, tidal volume of 5 ml/kg and > 35% of hematocrit (these may be evaluated by arterial blood gas analysis).

Disqualifiers

Parents or guardians' decision not to participate.

Major congenital anomalies or chromosomal abnormalities

Need for surgery or more than grade 2nd of IVH before randomization.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HFOV

    Device

    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.

  • CMV

    Device

    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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: high frenquency oscillation ventilation (HFOV)Experimental treatment 1 intervention
Group B: conventional mechanical ventilation (CMV)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

the incidence of bronchopulmonary dysplasia(BPD)

BPD is defined according to the 2019 diagnostic criteria. For infants discharged before 36 weeks' GA, BPD severity was assessed based on respiratory support at the time of discharge. Infants receiving no supplemental respiratory support were divided into no BPD, those treated with nasal cannula (≤ 2 L/min) as grade 1 BPD, those treated with nasal cannula (\> 2 L/min) or noninvasive positive airway pressure as grade 2 BPD and those treated with invasive mechanical ventilation as grade 3 BPD.

Time frame
36 weeks' gestational age

Secondary outcomes

1

duration of invasive ventilation

duration of invasive ventilation for HFOV or CMV

Time frame
36 weeks' gestational age
2

mortality

the included neonates were diagnosed with death

Time frame
36 weeks' gestational age or before discharge
3

air leak (pneumothorax and/or pneumomediastinum) occurred

the included neonates were diagnosed with air leak

Time frame
36 weeks' gestational age or before discharge
4

the incidence of hemodynamically significant patent ductus arteriosus (hsPDA)

the included neonates were diagnosed with hsPDA.

Time frame
36 weeks' gestational age or before discharge

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Children's Hospital of Chongqing Medical University

Sponsor institution

Children's Hospital of Chongqing Medical University

Collaborator

Jiulongpo No.1 People's Hospital

Collaborator

Chongqing Maternal and Child Health Hospital

Collaborator

The First Affiliated Hospital of Anhui Medical University

Collaborator

Children's Hospital of The Capital Institute of Pediatrics

Collaborator

Peking University Third Hospital

Collaborator

First Hospital of Tsinghua University

Collaborator

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

Collaborator

First Affiliated Hospital of Chongqing Medical University

Collaborator

Quanzhou Children's Hospital

Collaborator

Xiamen Maternity & Child Care Hospital

Collaborator

Zhujiang Hospital

Collaborator

Nanfang Hospital, Southern Medical University

Collaborator

Guangdong Academy of Medical Science and General Hospital

Collaborator

Guangdong Women and Children Hospital

Collaborator

Women and Children's Health Hospital of Yulin

Collaborator

Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region

Collaborator

Second Affiliated Hospital of Guangzhou Medical University

Collaborator

Guiyang Maternal and Child Health Care Hospital

Collaborator

The First People's Hospital of Zunyi

Collaborator

Lanzhou University Second Hospital

Collaborator

Gansu Provincial Maternal and Child Health Care Hospital

Collaborator

LanZhou University

Collaborator

First Affiliated Hospital of Harbin Medical University

Collaborator

First Affiliated Hospital of Xinjiang Medical University

Collaborator

Zhengzhou Children's Hospital, China

Collaborator

Third Affiliated Hospital of Zhengzhou University

Collaborator

the Maternal and Child Health Hospital of Hainan Province

Collaborator

Bethune International Peace Hospital

Collaborator

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

Collaborator

Children's Hospital of Nanjing Medical University

Collaborator

The First Hospital of Jilin University

Collaborator

Children's Hospital of Fudan University

Collaborator

Maternal and Children's Healthcare Hospital of Taian

Collaborator

The Second Hospital of Shandong University

Collaborator

Shanxi Provincial Maternity and Children's Hospital

Collaborator

Chengdu Women and Children's Center Hospital

Collaborator

The Affiliated Hospital Of Southwest Medical University

Collaborator

Affiliated Hospital of Southwest Medical University

Collaborator

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

Collaborator

Tianjin Central Hospital of Gynecology Obstetrics

Collaborator

People's Hospital of Xinjiang Uygur Autonomous Region

Collaborator

Kunming Children's Hospital

Collaborator

The First People's Hospital of Yunnan

Collaborator

First Affiliated Hospital of Kunming Medical University

Collaborator

Yan'an Affiliated Hospital of Kunming Medical University

Collaborator

Women and Children's Health Hospital of Qujing

Collaborator

The People's Hospital of Dehong Autonomous Prefecture

Collaborator

The First People's Hospital of Yinchuan

Collaborator

The Children's Hospital of Zhejiang University School of Medicine

Collaborator

Women's Hospital School Of Medicine Zhejiang University

Collaborator

Beijing 302 Hospital

Collaborator

Hunan Children's Hospital

Collaborator

Women and Children Hospital of Qinghai Province

Collaborator

Jiangxi Province Children's Hospital

Collaborator

Inner Mongolia People's Hospital

Collaborator

Mianyang Central Hospital

Collaborator

People's Liberation Army No.202 Hospital

Collaborator

Ningbo Women & Children's Hospital

Collaborator

Shanghai Children's Medical Center

Collaborator

First Affiliated Hospital of Guangxi Medical University

Collaborator

Nanjing Medical University

Collaborator

Xianyang Children's Hospital

Collaborator

Qinhuangdao Maternal and Child Health Care Hospital

Collaborator

Xuzhou Children Hospital

Collaborator

Source ClinicalTrials.gov
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