Risk Factors, Clinical Course, Treatment and Prognosis of Neonatal Acute Respiratory Distress Syndrome (ARDS): A Prospective, Observational Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neonatal Acute Respiratory Distress Syndrome(ARDS)
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Enrollment
- 1000
- Locations
- 2
- Primary Endpoint
- bronchopulmonary dysplasia(BPD)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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, 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.
Investigators
Ma Juan
Principal Investigator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Eligibility Criteria
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 / mm
- •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 / mm
- •Patients beyond the first month of life
Outcomes
Primary Outcomes
bronchopulmonary dysplasia(BPD)
Time Frame: before discharge or 36 weeks' gestational age
the incidence of BPD in infants with neonatal ARDS
Secondary Outcomes
- risk factors for ARDS(before discharge or 36 weeks' gestational age)
- death(before discharge or 36 weeks' gestational age)
- epidemiological characteristics in infants with neonatal ARDS(before discharge or 36 weeks' gestational age)
- intraventricular hemorrhage（IVH）(before discharge or 36 weeks' gestational age)
- retinopathy of prematurity(ROP)(before discharge or 36 weeks' gestational age)
- bronchopulmonary dysplasia(BPD) and/or death(before discharge or 36 weeks' gestational age)
- sepsis(before discharge or 36 weeks' gestational age)
- necrotizing enterocolitis(NEC)(before discharge or 36 weeks' gestational age)