Epidemiological Study of Neonatal Acute Respiratory Distress Syndrome (ARDS)

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University1,000 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Neonatal Acute Respiratory Distress Syndrome(ARDS)

Interventions

no interventionOTHER

no intervention was given

Eligibility

Sex: ALLMin age: 1 MinuteMax age: 1 Month

Medical Language ↔ Plain English

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

Locations (2)

Department of Pediatrics, Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, China

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Chongqing, China