Status:
COMPLETED
Epidemiological Study of Neonatal Acute Respiratory Distress Syndrome (ARDS)
Lead Sponsor:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Collaborating Sponsors:
Daping Hospital of Army Medical University
Jiulongpo No.1 People's Hospital
Conditions:
Neonatal Acute Respiratory Distress Syndrome(ARDS)
Eligibility:
All Genders
1-1 years
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, refracto...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03311165
Start Date
January 1 2018
End Date
June 30 2019
Last Update
January 9 2020
Active Locations (2)
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1
Department of Pediatrics, Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China, 400042
2
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, China