Acute Respiratory Distress Syndrome(ARDS) in Neonates
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03227289|
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : September 25, 2019
|Condition or disease||Intervention/treatment|
|ARDS NRDS||Other: Stayed in NRDS Other: Converted to ARDS|
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Pregnancy Risk Factors Promote Conversion From Neonatal Respiratory Distress Syndrome(NRDS) to Acute Respiratory Distress Syndrome(ARDS) : a Observational Cohort Study|
|Actual Study Start Date :||August 1, 2015|
|Actual Primary Completion Date :||July 30, 2018|
|Estimated Study Completion Date :||July 30, 2021|
Stayed in NRDS
The neonates with NRDS are stayed in NRDS
Other: Stayed in NRDS
The neonates with NRDS are stayed in NRDS.
Converted to ARDS
The neonates with NRDS are converted to ARDS
Other: Converted to ARDS
The neonates with NRDS are converted to ARDS.
- the effects of Pregnancy risk factors (PRF) on the conversion from NRDS to ARDS [ Time Frame: within 28 days ]the effects of Pregnancy risk factors (PRF) on the conversion from NRDS to ARDS
- clarify whether PRF treatment could prevention from conversion from NRDS to ARDS [ Time Frame: within 28 days ]clarify whether PRF treatment could prevention from conversion from NRDS to ARDS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03227289
|Contact: Ma Juan, MDemail@example.com|
|Contact: Ma Juan, MDfirstname.lastname@example.org|
|Department of Pediatrics, Daping Hospital, Third Military Medical University||Recruiting|
|Chongqing, Chongqing, China, 400042|
|Contact: Juan Ma, physician 18680887330 email@example.com|
|Study Director:||Shi Yuan, PhD,MD||Daping Hospital and the Research Institute of Surgery of the Third Military Medical University|