Acute Respiratory Distress Syndrome, Conventional Mechanical Ventilation, High Frequency Oscillation Ventilation
Conditions
Brief summary
Acute respiratory distress syndrome (ARDS) in neonates has been defined in 2017.The death rate is over 50%. HFOV and CMV are two main invasive ventilation strategies. However, which one is better needing to be further elucidated.
Detailed description
Severe acute respiratory distress syndrome (ARDS) is one of the serious complications in critically ill neonates. It can result in severe hypoxemia refractory to mechanical ventilation. Usually, invasive ventilation with low parameters is enough for neonates with mild and moderate ARDS. And extracorporeal membrane oxygenation is used to neonates with severe ARDS. However, extracorporeal membrane oxygenation can also lead to high death rate and need more technique and conditions. Mechanical ventilation with higher parameters was a substitute for such situations, but the death rate, complications and injuries of higher parameters is unknown. The purpose of the present study was to compare HFOV with CMV as invasive respiratory support strategies on decrease the mortality and morbidities in neonate with ARDS.
Interventions
DEVICEHFOV
Ventilated infants were randomized to HFOV
DEVICECMV
Ventilated infants were randomized to CMV.
Sponsors
Children's Hospital of Chongqing Medical University
Jiulongpo No.1 People's Hospital
Chongqing Maternal and Child Health Hospital
The First Affiliated Hospital of Anhui Medical University
Children's Hospital of The Capital Institute of Pediatrics
Peking University Third Hospital
First Hospital of Tsinghua University
Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital
First Affiliated Hospital of Chongqing Medical University
Quanzhou Children's Hospital
Xiamen Maternity & Child Care Hospital
Zhujiang Hospital
Guangdong Academy of Medical Science and General Hospital
Guangdong Women and Children Hospital
Women and Children's Health Hospital of Yulin
Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
Xianyang Children's Hospital
Second Affiliated Hospital of Guangzhou Medical University
Guiyang Maternal and Child Health Care Hospital
The First People's Hospital of Zunyi
Lanzhou University Second Hospital
Gansu Provincial Maternal and Child Health Care Hospital
LanZhou University
First Affiliated Hospital of Harbin Medical University
First Affiliated Hospital of Xinjiang Medical University
Zhengzhou Children's Hospital, China
Third Affiliated Hospital of Zhengzhou University
the Maternal and Child Health Hospital of Hainan Province
Bethune International Peace Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Children's Hospital of Nanjing Medical University
The First Hospital of Jilin University
Children's Hospital of Fudan University
Maternal and Children's Healthcare Hospital of Taian
The Second Hospital of Shandong University
Shanxi Provincial Maternity and Children's Hospital
Chengdu Women and Children's Center Hospital
The Affiliated Hospital Of Southwest Medical University
Affiliated Hospital of Southwest Medical University
Shenzhen People's Hospital, The Second Medical College of Jinan University
Tianjin Central Hospital of Gynecology Obstetrics
People's Hospital of Xinjiang Uygur Autonomous Region
Kunming Children's Hospital
The First People's Hospital of Yunnan
First Affiliated Hospital of Kunming Medical University
Yan'an Affiliated Hospital of Kunming Medical University
Women and Children's Health Hospital of Qujing
The People's Hospital of Dehong Autonomous Prefecture
The First People's Hospital of Yinchuan
The Children's Hospital of Zhejiang University School of Medicine
Women's Hospital School Of Medicine Zhejiang University
Beijing 302 Hospital
Hunan Children's Hospital
Women and Children Hospital of Qinghai Province
Jiangxi Province Children's Hospital
Inner Mongolia People's Hospital
Mianyang Central Hospital
People's Liberation Army No.202 Hospital
Ningbo Women & Children's Hospital
Shanghai Children's Medical Center
First Affiliated Hospital of Guangxi Medical University
Nanjing Medical University
Qinhuangdao Maternal and Child Health Care Hospital
Xuzhou Children Hospital
The First Affiliated Hospital of Zhengzhou University
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
When the neonate had fulfilled the included criteria, selective HFOV or CMV were started immediately on the basis of the group assignment.
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 12 Hours
Healthy volunteers
No
Inclusion criteria
* Gestational age (GA) between 25+0 and 34+0 weeks; * Assisted with CMV within 12 h after birth; * Diagnosis with ARDS; * 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 and \> 35% of hematocrit
Exclusion criteria
* parents' decision not to participate; * Major congenital anomalies or chromosomal abnormalities; * Upper respiratory tract abnormalities; * need for surgery before randomization; * Grade Ⅲ-IV-intraventricular hemorrhage (IVH).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the incidence of bronchopulmonary dysplasia (BPD) | 28 days after birth or 36 weeks'gestational age | the included neonate was diagnosed with BPD |
| Death | 28 days after birth or 36 weeks'gestational age or before discharge | the included preterm infants were dead |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraventricular hemorrhage | 28 days after birth or 36 weeks'gestational age or before discharge | Intraventricular hemorrhage was diagnosed |
| the incidence of neonatal necrotizing enterocolitis(NEC) | 28 days after birth or 36 weeks'gestational age or before discharge | the included neonate was diagnosed with NEC |
| the incidence of airleak | 28 days after birth or 36 weeks'gestational age or before discharge | the included neonate was diagnosed with airleak |
| composite mortality/BPD | 28 days after birth or 36 weeks'gestational age or before discharge | composite mortality/BPD was diagnosed |
| the incidence of retinopathy of prematurity(ROP) | 28 days after birth or 36 weeks'gestational age or before discharge | the included neonate was diagnosed with ROP |
Countries
China
Outcome results
None listed