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Trial record 46 of 199 for:    Recruiting, Not yet recruiting, Available Studies | Neonatal respiratory distress syndrome

Acute Respiratory Distress Syndrome(ARDS) in Neonates

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ClinicalTrials.gov Identifier: NCT03227289
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Ma Juan, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment
ARDS NRDS Other: Stayed in NRDS Other: Converted to ARDS

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
The gestational age was less than 37 weeks;
Criteria

Inclusion Criteria:

  1. The gestational age was less than 37 weeks;
  2. 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.
  3. informed parental consent has been obtained

Exclusion Criteria:

  1. parents' decision not to participate;
  2. major congenital anomalies;
  3. died or left the neonatal intensive care unit(NICU) within 24 hour.

Information from the National Library of Medicine

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


Contacts
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Contact: Ma Juan, MD 13508300283 476679422@qq.com
Contact: Ma Juan, MD 1388.559467 476679422@qq.com

Locations
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China, Chongqing
Department of Pediatrics, Daping Hospital, Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400042
Contact: Juan Ma, physician    18680887330    zoe330@163.com   
Sponsors and Collaborators
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Investigators
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Study Director: Shi Yuan, PhD,MD Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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Responsible Party: Ma Juan, Principal Investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier: NCT03227289     History of Changes
Other Study ID Numbers: ARDS
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury