Epidemiological Study of Neonatal Acute Respiratory Distress Syndrome (ARDS)

Risk Factors, Clinical Course, Treatment and Prognosis of Neonatal Acute Respiratory Distress Syndrome (ARDS): A Prospective, Observational Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Acute Respiratory Distress Syndrome(ARDS)
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• China
  • Chongqing, China
    • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Department of Pediatrics, Daping Hospital, Third Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

the definition of neonatal ARDS applies to infants from birth until 44 weeks, post-menstrual age or until 4 weeks, postnatal age (for neonates born after 40 weeks, post-menstrual age) to account for the role of prematurity; ARDS in infants older than these age limits should be diagnosed according to PALICC definition

Description

Inclusion Criteria:

• Acute onset (ie, within one week) from a known or suspected clinical insult
• Exclusion criteria: RDS, TTN, or congenital anomalies as a primary current acute respiratory condition
• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bronchopulmonary dysplasia(BPD)	the incidence of BPD in infants with neonatal ARDS	before discharge or 36 weeks' gestational age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
risk factors for ARDS	to determine risk factors leading to ARDS	before discharge or 36 weeks' gestational age
death	the mortality in infants with neonatal ARDS	before discharge or 36 weeks' gestational age
epidemiological characteristics in infants with neonatal ARDS	to describe the epidemiological characteristics in infants with neonatal ARDS	before discharge or 36 weeks' gestational age
intraventricular hemorrhage（IVH）	the incidence of IVH in infants with neonatal ARDS	before discharge or 36 weeks' gestational age
retinopathy of prematurity(ROP)	the incidence of ROP in infants with neonatal ARDS	before discharge or 36 weeks' gestational age
sepsis	the incidence of sepsis in infants with neonatal ARDS	before discharge or 36 weeks' gestational age
bronchopulmonary dysplasia(BPD) and/or death	the incidence of BPD and/or death in infants with neonatal ARDS	before discharge or 36 weeks' gestational age
necrotizing enterocolitis(NEC)	the incidence of NEC in infants with neonatal ARDS	before discharge or 36 weeks' gestational age

Collaborators and Investigators

• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Collaborators: 307 Hospital of PLA; The First Affiliated Hospital of Anhui Medical University; Beijing 302 Hospital; Southwest Hospital, China; Nanfang Hospital of Southern Medical University; The First Affiliated Hospital of Zhengzhou University; Children's Hospital of Fudan University; Shanghai Children's Medical Center; Shaanxi Provincial People's Hospital; Zhujiang Hospital; The First Hospital of Jilin University; People's Hospital of Xinjiang Uygur Autonomous Region; The Second Hospital of Shandong University; Guilin Medical College; Second Affiliated Hospital of Guangzhou Medical University; First Affiliated Hospital of Xinjiang Medical University; Bethune International Peace Hospital; First Affiliated Hospital of Chongqing Medical University; Navy General Hospital, Beijing; First Affiliated Hospital of Harbin Medical University; Hunan Children's Hospital; Inner Mongolia People's Hospital; Jiangxi Province Children's Hospital; Zhengzhou Children's Hospital, China; Quanzhou Children's Hospital; Children's Hospital of Chongqing Medical University; Tianjin Central Hospital of Gynecology Obstetrics; Shanxi Provincial Maternity and Children's Hospital; Yan'an Affiliated Hospital of Kunming Medical University; Children's Hospital of Nanjing Medical University; the PLA General Hospital; Lanzhou General Hospital of PLA; Chengdu Women and Children's Center Hospital; Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region; Ningbo Women & Children's Hospital; The 306 Hospital of People's Liberation Army; Jiulongpo No.1 People's Hospital; Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital; Guiyang Maternal and Child Health Care Hospital; the Maternal and Child Health Hospital of Hainan Province; Maternal and Children's Healthcare Hospital of Taian; The People's Hospital of Dehong Autonomous Prefecture; Women and Children Hospital of Qinghai Province; People's Liberation Army No.202 Hospital; Daping Hospital of Army Medical University; The Second Affiliated Hospital of the Army Medical University; The 251st hosptital of PLA; The Second Military Medical University Changhai Hospital; The PLA Rocket Force general hospital; the 252th Hospital of PLA; Wuhan general hospital of PLA; Jinan general hospital of PLA; The 452nd hospital of PLA; Xijing Hospital，FMMU; The 88th Hospital of PLA; The 155th hosptital of PLA; General Hospital of Xinjiang Military Area; Guangzhou general hospital of PLA; The 211st hospital of PLA; Shenyang General Hospital of PLA; Shandong Maternal and Child Health Hospital; Newborn Department of Ankang City Central Hospital of Shaanxi Province; the Second Hospital of Xian Jiao Tong University; Hunan Maternal and Children Health Hospital; Yinchuan No.1 people Hospital; First people Hospital of Kashi; General Hospital of Tibet Military Region; Zhang Ye Pepole Hospital of HeXi University; Hospital (T.C.M）Affiliated to Southwest Medical University; Tongji Medical College,Huazhong University of Science &Techonlogy; South Paris University Hospitals
• Investigators: Principal Investigator: Shi Yuan, PhD,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (Actual): October 17, 2017

Study Record Updates

• Last Update Posted (Actual): January 9, 2020
• Last Update Submitted That Met QC Criteria: January 7, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: prognosis; Acute Respiratory Distress Syndrome; neonate; risk factor; clinical course
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 201726

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No