Acute Respiratory Distress Syndrome(ARDS) in Neonates

Study Overview
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Brief Summary
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Acute respiratory distress syndrome in neonates has been defined in 2015. Earlier identification and successful intervention into the potential pregnancy associated risk factors for the conversion from NRDS to ARDS is one of the most important components of ARDS prevention.

Detailed Description
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Pregnancy risk factors (PRF), such as intrahepatic cholestasis during pregnancy(ICP), hypertensive disorder complicating pregnancy(HDCP) and gestational diabetes mellitus(GDM), are related to NRDS, ARDS and subsequent death. Meantime, it has also been proven that the prevention of PRF reduces the risk of NRDS and ARDS. However, few study reported the relations between PRF and the conversion from NRDS to ARDS, and it also remains unknown whether treating PRF can reduce the progression from NRDS to ARDS. We have found that PRF were related to the increase and deterioration of NRDS in a Chinese cohort. The aims of the present study were: 1). to report the effects of PRF on the conversion from NRDS to ARDS. 2). to clarify whether PRF treatment could prevention from conversion from NRDS to ARDS in a Chinese population.

Official Title
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Pregnancy Risk Factors Promote Conversion From Neonatal Respiratory Distress Syndrome(NRDS) to Acute Respiratory Distress Syndrome(ARDS) : a Observational Cohort Study

Conditions
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ARDS, NRDS

Intervention / Treatment
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* Other: Stayed in NRDS
* Other: Converted to ARDS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The gestational age was less than 37 weeks; These neonates were diagnosed with NRDS; The diagnosis of NRDS was based on clinical manifestations and chest X-ray findings. The clinical signs and symptoms of NRDS were respiratory distress, tachypnea, nasal flaring, groan, and cyanosis after birth. The typical X-ray picture of RDS showed a grain shadow, air bronchogram or white lung. informed parental consent has been obtained Exclusion Criteria: parents' decision not to participate; major congenital anomalies; died or left the neonatal intensive care unit(NICU) within 24 hour.

Ages Eligible for Study
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Minimum Age: 5 Minutes
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stayed in NRDS<br>The neonates with NRDS are stayed in NRDS | Other: Stayed in NRDS<br>* The neonates with NRDS are stayed in NRDS.<br>|
| Converted to ARDS<br>The neonates with NRDS are converted to ARDS | Other: Converted to ARDS<br>* The neonates with NRDS are converted to ARDS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effects of Pregnancy risk factors (PRF) on the conversion from NRDS to ARDS | the effects of Pregnancy risk factors (PRF) on the conversion from NRDS to ARDS | within 28 days | 
| clarify whether PRF treatment could prevention from conversion from NRDS to ARDS | clarify whether PRF treatment could prevention from conversion from NRDS to ARDS | within 28 days |