Clinical trial NCT03311165: Epidemiological Study of Neonatal Acute Respiratory Distress Syndrome (ARDS)
Official title: Risk Factors, Clinical Course, Treatment and Prognosis of Neonatal Acute Respiratory Distress Syndrome (ARDS): A Prospective, Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Acute Respiratory Distress Syndrome(ARDS)
Keywords: neonate
Acute Respiratory Distress Syndrome
prognosis
risk factor
clinical course
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
Collaborators: name: Daping Hospital of Army Medical University
name: Jiulongpo No.1 People's Hospital
name: Children's Hospital of Chongqing Medical University
name: Lanzhou General Hospital of PLA
name: First Affiliated Hospital of Chongqing Medical University
name: Southwest Hospital, China
name: Guiyang Maternal and Child Health Care Hospital
name: Chengdu Women and Children's Center Hospital
name: The Second Affiliated Hospital of the Army Medical University
name: Zhujiang Hospital
name: People's Liberation Army No.202 Hospital
name: Bethune International Peace Hospital
name: The 251st hosptital of PLA
name: People's Hospital of Xinjiang Uygur Autonomous Region
name: The Second Military Medical University Changhai Hospital
name: The PLA Rocket Force general hospital
name: the 252th Hospital of PLA
name: Hunan Children's Hospital
name: Wuhan general hospital of PLA
name: Jinan general hospital of PLA
name: The 306 Hospital of People's Liberation Army
name: The 452nd hospital of PLA
name: Xijing Hospital，FMMU
name: 307 Hospital of PLA
name: The 88th Hospital of PLA
name: Tianjin Central Hospital of Gynecology Obstetrics
name: Beijing 302 Hospital
name: First Affiliated Hospital of Xinjiang Medical University
name: Nanfang Hospital, Southern Medical University
name: Children's Hospital of Fudan University
name: Shanxi Provincial Maternity and Children's Hospital
name: the PLA General Hospital
name: The 155th hosptital of PLA
name: General Hospital of Xinjiang Military Area
name: Guangzhou general hospital of PLA
name: The 211st hospital of PLA
name: First Affiliated Hospital of Harbin Medical University
name: Maternal and Children's Healthcare Hospital of Taian
name: Zhengzhou Children's Hospital, China
name: Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
name: Shenyang General Hospital of PLA
name: The First Affiliated Hospital of Anhui Medical University
name: Yan'an Affiliated Hospital of Kunming Medical University
name: Inner Mongolia People's Hospital
name: Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital
name: Children's Hospital of Nanjing Medical University
name: The First Hospital of Jilin University
name: Shanghai Children's Medical Center
name: Ningbo Women & Children's Hospital
name: Shandong Maternal and Child Health Hospital
name: Guilin Medical College
name: Women and Children Hospital of Qinghai Province
name: Quanzhou Children's Hospital
name: Newborn Department of Ankang City Central Hospital of Shaanxi Province
name: the Second Hospital of Xian Jiao Tong University
name: The Second Hospital of Shandong University
name: Hunan Maternal and Children Health Hospital
name: The First People's Hospital of Yinchuan
name: The First Affiliated Hospital of Zhengzhou University
name: The People's Hospital of Dehong Autonomous Prefecture
name: First people Hospital of Kashi
name: General Hospital of Tibet Military Region
name: Navy General Hospital, Beijing
name: Second Affiliated Hospital of Guangzhou Medical University
name: Jiangxi Province Children's Hospital
name: the Maternal and Child Health Hospital of Hainan Province
name: Zhang Ye Pepole Hospital of HeXi University
name: Shaanxi Provincial People's Hospital
name: Hospital (T.C.M）Affiliated to Southwest Medical University
name: Tongji Medical College,Huazhong University of Science &Techonlogy
name: South Paris University Hospitals
First posted: 2017-10-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the definition of neonatal ARDS applies to infants from birth until 44 weeks, post-menstrual age or until 4 weeks, postnatal age (for neonates born after 40 weeks, post-menstrual age) to account for the role of prematurity; ARDS in infants older than these age limits should be diagnosed according to PALICC definition

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.

Eligibility criteria: 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

Exclusion Criteria:

* Hyaline Membrane Disease defined as:

Mandatory criteria : defined as respiratory distress syndrome appearing within the first 24 hours of life, with response to surfactant and / or volume recruitment. Additional criteria : Lung imaging Supporting the diagnosis and / or lamellar body counts \< 30,000 / mm3.

* Transient tachypnea of the neonate (wet lung) defined as:

Mandatory criteria : defined as mild ( Silverman score ≤3 ) respiratory distress appearing within the first 24 hours of life and ending within the first 48 hours of life, needing only oxygen administration and / or CPAP. Additional criteria : Lung imaging Supporting the diagnosis and / or lamellar body counts \> 30,000 / mm3.

- Patients beyond the first month of life

Primary outcomes:
measure: bronchopulmonary dysplasia(BPD)
timeFrame: before discharge or 36 weeks' gestational age
Secondary outcomes:
measure: risk factors for ARDS
timeFrame: before discharge or 36 weeks' gestational age
measure: death
timeFrame: before discharge or 36 weeks' gestational age
measure: epidemiological characteristics in infants with neonatal ARDS
timeFrame: before discharge or 36 weeks' gestational age
measure: intraventricular hemorrhage（IVH）
timeFrame: before discharge or 36 weeks' gestational age
measure: retinopathy of prematurity(ROP)
timeFrame: before discharge or 36 weeks' gestational age
measure: sepsis
timeFrame: before discharge or 36 weeks' gestational age
measure: bronchopulmonary dysplasia(BPD) and/or death
timeFrame: before discharge or 36 weeks' gestational age
measure: necrotizing enterocolitis(NEC)
timeFrame: before discharge or 36 weeks' gestational age
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Pediatrics, Daping Hospital, Third Military Medical University
state: Chongqing
city: Chongqing
country: China
facility: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study officials:
affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: Shi Yuan, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen L, Li J, Shi Y; Chinese Neonatal ARDS (ChiNARDS) study group. Clinical characteristics and outcomes in neonates with perinatal acute respiratory distress syndrome in China: A national, multicentre, cross-sectional study. EClinicalMedicine. 2022 Nov 12;55:101739. doi: 10.1016/j.eclinm.2022.101739. eCollection 2023 Jan.