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Epidemiological Study of Neonatal Acute Respiratory Distress Syndrome (ARDS)

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ClinicalTrials.gov Identifier: NCT03311165
Recruitment Status : Unknown
Verified October 2017 by Ma Juan, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
Recruitment status was:  Recruiting
First Posted : October 17, 2017
Last Update Posted : December 12, 2017
Sponsor:
Collaborators:
Daping Hospital of Army Medical University
Jiulongpo No.1 People's Hospital
Guiyang Maternity and Child Health Care Hospital
Yan'an Affiliated Hospital of Kunming Medical University
The Children's Hospital of Zhejiang University School of Medicine
Lanzhou General Hospital of PLA
Changhai hospital of Navy Medical University
General hospital of Rocket Army
No 252 hospital of PLA
No 301 hospital of PLA
No 88 hospital of PLA
Xinqiao hospital of Army Medical University
Bethune International Peace Hospital
No 251 hospital of PLA
People's Hospital of Xinjiang Uygur Autonomous Region
Children's Hospital of Chongqing Medical University
Gansu Provincial Maternity and Child-Care Hospital
Chengdu Women and Children's Center Hospital
Children hospital of Hunan Province
Wuhan general hospital of PLA
Jinan general hospital of PLA
The 306 Hospital of People's Liberation Army
No 452 hospital of PLA
Xijing hospital of air force Medical University
307 Hospital of PLA
No 202 hospital of PLA
Tianjin armed police children hospital
Beijing 302 Hospital
Xinan hospital of Army Medical University
Southern Medical University, China
Children Hospital of Fudan University
NorthWest Women and Children Hospital
First Affiliated Hospital of Xinjiang Medical University
No 155 hospital of PLA
Guangzhou general hospital of PLA
Urumqi general hospital of PLA
No 211 hospital of PLA
First Affiliated Hospital of Harbin Medical University
Information provided by (Responsible Party):
Ma Juan, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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.

Condition or disease Intervention/treatment
Neonatal Acute Respiratory Distress Syndrome(ARDS) Other: no intervention

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Risk Factors, Clinical Course, Treatment and Prognosis of Neonatal Acute Respiratory Distress Syndrome (ARDS): A Prospective, Observational Cohort Study
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018



Intervention Details:
  • Other: no intervention
    no intervention was given


Primary Outcome Measures :
  1. risk factors [ Time Frame: within 2 years ]
    which risk factors,such as intrahepatic cholestasis during pregnancy(ICP), pernicious placenta previa (PPP), hypertensive disorder complicating pregnancy(HDCP) and gestational diabetes mellitus(GDM), were easy to induce neonatal ARDS

  2. mortality [ Time Frame: within 2 years ]
    the neonates with ARDS was dead

  3. clinical course [ Time Frame: within 2 years ]
    the main clinical presentation

  4. treatment [ Time Frame: within 2 years ]
    what treatment may be used.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All neonates diagnosed with ARDS.
Criteria

Inclusion Criteria:

  • Acute onset (ie, within one week) from a known or suspected clinical insult
  • 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
  • Mild ARDS: 4≤OI<8;Moderate ARDS: 8≤OI<16;Severe ARDS: OI≥16

Exclusion Criteria:

  • RDS, transient tachypnoea of the neonate(TTN), or congenital anomalies as a primary current acute respiratory condition
  • 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

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): NCT03311165


Contacts
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Contact: Ma Juan, MD 18680887330 petshi530@vip.163.com
Contact: Chen Long, PhD,MD 13883559467 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: Ma Juan, MD    18680887330    zoe330@163.com   
China
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Recruiting
Chongqing, China
Contact: Chen Long, PhD,MD    13883559467    476679422@qq.com   
Contact: Shi Yuan, PhD,MD         
Sponsors and Collaborators
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Daping Hospital of Army Medical University
Jiulongpo No.1 People's Hospital
Guiyang Maternity and Child Health Care Hospital
Yan'an Affiliated Hospital of Kunming Medical University
The Children's Hospital of Zhejiang University School of Medicine
Lanzhou General Hospital of PLA
Changhai hospital of Navy Medical University
General hospital of Rocket Army
No 252 hospital of PLA
No 301 hospital of PLA
No 88 hospital of PLA
Xinqiao hospital of Army Medical University
Bethune International Peace Hospital
No 251 hospital of PLA
People's Hospital of Xinjiang Uygur Autonomous Region
Children's Hospital of Chongqing Medical University
Gansu Provincial Maternity and Child-Care Hospital
Chengdu Women and Children's Center Hospital
Children hospital of Hunan Province
Wuhan general hospital of PLA
Jinan general hospital of PLA
The 306 Hospital of People's Liberation Army
No 452 hospital of PLA
Xijing hospital of air force Medical University
307 Hospital of PLA
No 202 hospital of PLA
Tianjin armed police children hospital
Beijing 302 Hospital
Xinan hospital of Army Medical University
Southern Medical University, China
Children Hospital of Fudan University
NorthWest Women and Children Hospital
First Affiliated Hospital of Xinjiang Medical University
No 155 hospital of PLA
Guangzhou general hospital of PLA
Urumqi general hospital of PLA
No 211 hospital of PLA
First Affiliated Hospital of Harbin Medical University
Investigators
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Principal Investigator: Shi Yuan, PhD,MD Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Additional Information:

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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: NCT03311165     History of Changes
Other Study ID Numbers: 201726
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: October 2017
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
Keywords provided by Ma Juan, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University:
neonate
Acute Respiratory Distress Syndrome
prognosis
risk factor
clinical course
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury