Epidemiological Study of Neonatal Acute Respiratory Distress Syndrome (ARDS)

NCT ID: NCT03311165

Last Updated: 2020-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-06-30

Brief Summary

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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

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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.

Conditions

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Neonatal Acute Respiratory Distress Syndrome(ARDS)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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no intervention

no intervention was given

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Acute onset (ie, within one week) from a known or suspected clinical insult

Exclusion Criteria

* 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


* 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 / mm3.

* 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 / mm3.

\- Patients beyond the first month of life
Minimum Eligible Age

1 Minute

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daping Hospital of Army Medical University

OTHER

Sponsor Role collaborator

Jiulongpo No.1 People's Hospital

OTHER

Sponsor Role collaborator

Children's Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

Lanzhou General Hospital of PLA

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

Southwest Hospital, China

OTHER

Sponsor Role collaborator

Guiyang Maternal and Child Health Care Hospital

OTHER

Sponsor Role collaborator

Chengdu Women and Children's Center Hospital

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of the Army Medical University

UNKNOWN

Sponsor Role collaborator

Zhujiang Hospital

OTHER

Sponsor Role collaborator

People's Liberation Army No.202 Hospital

OTHER

Sponsor Role collaborator

Bethune International Peace Hospital

OTHER

Sponsor Role collaborator

The 251st hosptital of PLA

UNKNOWN

Sponsor Role collaborator

People's Hospital of Xinjiang Uygur Autonomous Region

OTHER

Sponsor Role collaborator

The Second Military Medical University Changhai Hospital

UNKNOWN

Sponsor Role collaborator

The PLA Rocket Force general hospital

UNKNOWN

Sponsor Role collaborator

the 252th Hospital of PLA

UNKNOWN

Sponsor Role collaborator

Hunan Children's Hospital

OTHER_GOV

Sponsor Role collaborator

Wuhan general hospital of PLA

UNKNOWN

Sponsor Role collaborator

Jinan general hospital of PLA

UNKNOWN

Sponsor Role collaborator

The 306 Hospital of People's Liberation Army

OTHER

Sponsor Role collaborator

The 452nd hospital of PLA

UNKNOWN

Sponsor Role collaborator

Xijing Hospital,FMMU

UNKNOWN

Sponsor Role collaborator

307 Hospital of PLA

OTHER

Sponsor Role collaborator

The 88th Hospital of PLA

UNKNOWN

Sponsor Role collaborator

Tianjin Central Hospital of Gynecology Obstetrics

OTHER

Sponsor Role collaborator

Beijing 302 Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role collaborator

Children's Hospital of Fudan University

OTHER

Sponsor Role collaborator

Shanxi Provincial Maternity and Children's Hospital

OTHER

Sponsor Role collaborator

the PLA General Hospital

UNKNOWN

Sponsor Role collaborator

The 155th hosptital of PLA

UNKNOWN

Sponsor Role collaborator

General Hospital of Xinjiang Military Area

UNKNOWN

Sponsor Role collaborator

Guangzhou general hospital of PLA

UNKNOWN

Sponsor Role collaborator

The 211st hospital of PLA

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

Maternal and Children's Healthcare Hospital of Taian

OTHER

Sponsor Role collaborator

Zhengzhou Children's Hospital, China

OTHER

Sponsor Role collaborator

Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region

OTHER

Sponsor Role collaborator

Shenyang General Hospital of PLA

UNKNOWN

Sponsor Role collaborator

The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

Yan'an Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role collaborator

Inner Mongolia People's Hospital

OTHER

Sponsor Role collaborator

Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital

OTHER

Sponsor Role collaborator

Children's Hospital of Nanjing Medical University

OTHER

Sponsor Role collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role collaborator

Shanghai Children's Medical Center

OTHER

Sponsor Role collaborator

Ningbo Women & Children's Hospital

OTHER

Sponsor Role collaborator

Shandong Maternal and Child Health Hospital

UNKNOWN

Sponsor Role collaborator

Guilin Medical College

OTHER

Sponsor Role collaborator

Women and Children Hospital of Qinghai Province

OTHER

Sponsor Role collaborator

Quanzhou Children's Hospital

OTHER

Sponsor Role collaborator

Newborn Department of Ankang City Central Hospital of Shaanxi Province

UNKNOWN

Sponsor Role collaborator

the Second Hospital of Xian Jiao Tong University

UNKNOWN

Sponsor Role collaborator

The Second Hospital of Shandong University

OTHER

Sponsor Role collaborator

Hunan Maternal and Children Health Hospital

UNKNOWN

Sponsor Role collaborator

The First People's Hospital of Yinchuan

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

The People's Hospital of Dehong Autonomous Prefecture

OTHER

Sponsor Role collaborator

First people Hospital of Kashi

UNKNOWN

Sponsor Role collaborator

General Hospital of Tibet Military Region

UNKNOWN

Sponsor Role collaborator

Navy General Hospital, Beijing

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

Jiangxi Province Children's Hospital

OTHER

Sponsor Role collaborator

the Maternal and Child Health Hospital of Hainan Province

OTHER

Sponsor Role collaborator

Zhang Ye Pepole Hospital of HeXi University

UNKNOWN

Sponsor Role collaborator

Shaanxi Provincial People's Hospital

OTHER

Sponsor Role collaborator

Hospital (T.C.M)Affiliated to Southwest Medical University

UNKNOWN

Sponsor Role collaborator

Tongji Medical College,Huazhong University of Science &Techonlogy

UNKNOWN

Sponsor Role collaborator

South Paris University Hospitals

UNKNOWN

Sponsor Role collaborator

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ma Juan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shi Yuan, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Locations

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Department of Pediatrics, Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Chongqing, , China

Site Status

Countries

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China

References

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Chen L, Li J, Shi Y; Chinese Neonatal ARDS (ChiNARDS) study group. Clinical characteristics and outcomes in neonates with perinatal acute respiratory distress syndrome in China: A national, multicentre, cross-sectional study. EClinicalMedicine. 2022 Nov 12;55:101739. doi: 10.1016/j.eclinm.2022.101739. eCollection 2023 Jan.

Reference Type DERIVED
PMID: 36386029 (View on PubMed)

Other Identifiers

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201726

Identifier Type: -

Identifier Source: org_study_id

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