NCT03311165

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 17, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

1.5 years

First QC Date

October 4, 2017

Last Update Submit

January 7, 2020

Conditions

Neonatal Acute Respiratory Distress Syndrome(ARDS)

Keywords

neonateAcute Respiratory Distress Syndromeprognosisrisk factorclinical course

Outcome Measures

Primary Outcomes (1)

  • bronchopulmonary dysplasia(BPD)

    the incidence of BPD in infants with neonatal ARDS

    before discharge or 36 weeks' gestational age

Secondary Outcomes (8)

  • risk factors for ARDS

    before discharge or 36 weeks' gestational age

  • death

    before discharge or 36 weeks' gestational age

  • epidemiological characteristics in infants with neonatal ARDS

    before discharge or 36 weeks' gestational age

  • intraventricular hemorrhage（IVH）

    before discharge or 36 weeks' gestational age

  • retinopathy of prematurity(ROP)

    before discharge or 36 weeks' gestational age

  • +3 more secondary outcomes

Interventions

no interventionOTHER

no intervention was given

Eligibility Criteria

Age1 Minute - 1 Month
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Pediatrics, Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

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

Chongqing, China

Location

Related Publications (1)

  • 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.

    PMID: 36386029DERIVED

MeSH Terms

Conditions

Respiratory Distress SyndromeDisease Progression

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shi Yuan, PhD,MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 4, 2017

First Posted

October 17, 2017

Study Start

January 1, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

January 9, 2020

Record last verified: 2020-01

Locations

CN(2)