Epidemiological Study of Neonatal Acute Respiratory Distress Syndrome (ARDS)

Army Medical University of People's Liberation Army

Status: Completed

Conditions: Neonatal Acute Respiratory Distress Syndrome(ARDS)

Treatments: Other: no intervention

Study type: Observational

Funder types: Other

Identifiers

NCT03311165

201726

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 patients

Sex: All

Ages: 1 minute to 1 month old

Volunteers: No Healthy Volunteers

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