Epidemiological Study of Neonatal Acute Respiratory Distress Syndrome (ARDS)

Completed

• Conditions: Neonatal Acute Respiratory Distress Syndrome(ARDS)

• Registration Number: NCT03311165
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-10-10
• Study First Posted: 2017-10-17
• Study Start: 2018-01-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-07
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
bronchopulmonary dysplasia(BPD)	before discharge or 36 weeks' gestational age	the incidence of BPD in infants with neonatal ARDS

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University; 🇨🇳 Chongqing, China

Department of Pediatrics, Daping Hospital, Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China