Heliox for Neonate With Acute Respiratory Distress Syndrome (ARDS)

ARDS Clinical Trial

Official title:

Heliox for Neonate With Acute Respiratory Distress Syndrome (ARDS): A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03217149
• Other study ID #: heliox for ARDS
• Status: Recruiting
• Phase: N/A
• First received: July 12, 2017
• Last updated: July 12, 2017
• Start date: September 1, 2017
• Est. completion date: August 30, 2020

Study information

• Verified date: July 2017
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: Ma Juan, MD
• Phone: 13883559467
• Email: 476679422[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acute respiratory distress syndrome (ARDS) in neonates has been defined, the role of heliox is not clear.This study aimed to determine whether ARDS neonate would benefit from heliox when oxygenation deteriorated on mechanical ventilation and to identify any potential risk factors related to mortality.

Description:

Acute respiratory distress syndrome (ARDS) can result in severe hypoxemia refractory to mechanical ventilation, mechanical ventilation including high frequency oscillation ventilation is the main method. But it is partial unuseful.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

1. infant less than 28 days

2. diagnosis of ARDS

3. informed parental consent has been obtained

Exclusion Criteria:

1. major congenital malformations or complex congenital heart disease

2. transferred out of the neonatal intensive care unit without treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• heliox combined with MV
heliox combined with MV is given to infant with ARDS
• MV
MV is given to infant with ARDS

Locations

Country	Name	City	State
China	Department of Pediatrics, Daping Hospital, Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death	death	within 100 days
Secondary	Bayley Scales of Infant Development	the survival is assessed by Bayley Scales of Infant Development	at 2 months old and 2 years old