NCT03311165

Epidemiological Study of Neonatal Acute Respiratory Distress Syndrome (ARDS)

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Academic / Other
• Sex: All
• Age: 1 Minute – 1 Month
• Healthy volunteers: —

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.

Conditions

• Neonatal Acute Respiratory Distress Syndrome(ARDS)

Interventions

Type	Name	Description
OTHER	no intervention	no intervention was given

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-06-30
• Completion: 2019-06-30
• First posted: 2017-10-17
• Last updated: 2020-01-09

Locations

2 sites across 1 country: China