Neonatal Acute Respiratory Distress Syndrome(ARDS)
Conditions
Keywords
neonate, Acute Respiratory Distress Syndrome, prognosis, risk factor, clinical course
Brief summary
Neonatal acute respiratory distress syndrome(ARDS) is a rare but often severe respiratory disorder. The incidence remains unclear and mortality is about 30%-60%. It is characterized by acute, refractory hypoxemia, persistent respiratory distress and decreased lung compliance. Evaluation and comparison of various clinical studies conducted were hindered by a lack of uniformity in diagnostic criteria.
Detailed description
In 2017, the neonatal acute respiratory distress syndrome(ARDS) Consortium Working Group has proposed diagnostic criteria for neonatal ARDS. The study consists of a prospective, multicentre, web-based,cohort study in China in which neonates who fulfil the new criteria definition are enrolled in order to: describe the epidemiology, clinical course, and prognosis of neonates affected by neonatal ARDS; identify a list of risk factors for neonatal ARDS, as it exists for adults and older children with ARDS; and guide future studies.
Interventions
OTHERno intervention
no intervention was given
Sponsors
Daping Hospital of Army Medical University
Jiulongpo No.1 People's Hospital
Children's Hospital of Chongqing Medical University
Lanzhou General Hospital of PLA
First Affiliated Hospital of Chongqing Medical University
Southwest Hospital, China
Guiyang Maternal and Child Health Care Hospital
Chengdu Women and Children's Center Hospital
The Second Affiliated Hospital of the Army Medical University
Zhujiang Hospital
People's Liberation Army No.202 Hospital
Bethune International Peace Hospital
The 251st hosptital of PLA
People's Hospital of Xinjiang Uygur Autonomous Region
The Second Military Medical University Changhai Hospital
The PLA Rocket Force general hospital
the 252th Hospital of PLA
Hunan Children's Hospital
Wuhan general hospital of PLA
Jinan general hospital of PLA
The 306 Hospital of People's Liberation Army
The 452nd hospital of PLA
Xijing Hospital，FMMU
307 Hospital of PLA
The 88th Hospital of PLA
Tianjin Central Hospital of Gynecology Obstetrics
Beijing 302 Hospital
First Affiliated Hospital of Xinjiang Medical University
Nanfang Hospital, Southern Medical University
Children's Hospital of Fudan University
Shanxi Provincial Maternity and Children's Hospital
the PLA General Hospital
The 155th hosptital of PLA
General Hospital of Xinjiang Military Area
Guangzhou general hospital of PLA
The 211st hospital of PLA
First Affiliated Hospital of Harbin Medical University
Maternal and Children's Healthcare Hospital of Taian
Zhengzhou Children's Hospital, China
Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
Shenyang General Hospital of PLA
The First Affiliated Hospital of Anhui Medical University
Yan'an Affiliated Hospital of Kunming Medical University
Inner Mongolia People's Hospital
Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital
Children's Hospital of Nanjing Medical University
The First Hospital of Jilin University
Shanghai Children's Medical Center
Ningbo Women & Children's Hospital
Shandong Maternal and Child Health Hospital
Guilin Medical College
Women and Children Hospital of Qinghai Province
Quanzhou Children's Hospital
Newborn Department of Ankang City Central Hospital of Shaanxi Province
the Second Hospital of Xian Jiao Tong University
The Second Hospital of Shandong University
Hunan Maternal and Children Health Hospital
The First People's Hospital of Yinchuan
The First Affiliated Hospital of Zhengzhou University
The People's Hospital of Dehong Autonomous Prefecture
First people Hospital of Kashi
General Hospital of Tibet Military Region
Navy General Hospital, Beijing
Second Affiliated Hospital of Guangzhou Medical University
Jiangxi Province Children's Hospital
the Maternal and Child Health Hospital of Hainan Province
Zhang Ye Pepole Hospital of HeXi University
Shaanxi Provincial People's Hospital
Hospital (T.C.M）Affiliated to Southwest Medical University
Tongji Medical College,Huazhong University of Science &Techonlogy
South Paris University Hospitals
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 1 Months
Inclusion criteria
* Acute onset (ie, within one week) from a known or suspected clinical insult *
Exclusion criteria
RDS, TTN, or congenital anomalies as a primary current acute respiratory condition * Diffuse, bilateral, and irregular opacities or infiltrates, or complete opacification of the lungs, which are not fully explained by local effusions, atelectasis, RDS, TTN, or congenital anomalies * Absence of congenital heart disease explaining the oedema (this includes ductus arteriosus with pulmonary overflow if no acute pulmonary haemorrhage exists). Echocardiography is needed to verify the origin of oedema. * Mild ARDS: 4≤OI\<8;Moderate ARDS: 8≤OI\<16;Severe ARDS: OI≥16
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bronchopulmonary dysplasia(BPD) | before discharge or 36 weeks' gestational age | the incidence of BPD in infants with neonatal ARDS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| death | before discharge or 36 weeks' gestational age | the mortality in infants with neonatal ARDS |
| epidemiological characteristics in infants with neonatal ARDS | before discharge or 36 weeks' gestational age | to describe the epidemiological characteristics in infants with neonatal ARDS |
| intraventricular hemorrhage（IVH） | before discharge or 36 weeks' gestational age | the incidence of IVH in infants with neonatal ARDS |
| risk factors for ARDS | before discharge or 36 weeks' gestational age | to determine risk factors leading to ARDS |
| sepsis | before discharge or 36 weeks' gestational age | the incidence of sepsis in infants with neonatal ARDS |
| bronchopulmonary dysplasia(BPD) and/or death | before discharge or 36 weeks' gestational age | the incidence of BPD and/or death in infants with neonatal ARDS |
| necrotizing enterocolitis(NEC) | before discharge or 36 weeks' gestational age | the incidence of NEC in infants with neonatal ARDS |
| retinopathy of prematurity(ROP) | before discharge or 36 weeks' gestational age | the incidence of ROP in infants with neonatal ARDS |
Countries
China
Outcome results
None listed