Epidemiological Study of Neonatal Acute Respiratory Distress Syndrome (ARDS)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Risk Factors, Clinical Course, Treatment and Prognosis of Neonatal Acute Respiratory Distress Syndrome (ARDS): A Prospective, Observational Cohort Study

Conditions
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Neonatal Acute Respiratory Distress Syndrome(ARDS)

Intervention / Treatment
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* Other: no intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 1 Month

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|no intervention was given|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bronchopulmonary dysplasia(BPD) | the incidence of BPD in infants with neonatal ARDS | before discharge or 36 weeks' gestational age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk factors for ARDS | to determine risk factors leading to ARDS | before discharge or 36 weeks' gestational age | 
| death | the mortality in infants with neonatal ARDS | before discharge or 36 weeks' gestational age | 
| epidemiological characteristics in infants with neonatal ARDS | to describe the epidemiological characteristics in infants with neonatal ARDS | before discharge or 36 weeks' gestational age | 
| intraventricular hemorrhage（IVH） | the incidence of IVH in infants with neonatal ARDS | before discharge or 36 weeks' gestational age | 
| retinopathy of prematurity(ROP) | the incidence of ROP in infants with neonatal ARDS | before discharge or 36 weeks' gestational age | 
| sepsis | the incidence of sepsis in infants with neonatal ARDS | before discharge or 36 weeks' gestational age | 
| bronchopulmonary dysplasia(BPD) and/or death | the incidence of BPD and/or death in infants with neonatal ARDS | before discharge or 36 weeks' gestational age | 
| necrotizing enterocolitis(NEC) | the incidence of NEC in infants with neonatal ARDS | before discharge or 36 weeks' gestational age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonate, Acute Respiratory Distress Syndrome, prognosis, risk factor, clinical course