Heliox for Neonate With Acute Respiratory Distress Syndrome (ARDS)

Army Medical University of People's Liberation Army

Status: Unknown

Conditions: ARDS

Treatments: Drug: MV; Drug: heliox combined with MV

Study type: Interventional

Funder types: Other

Identifiers

NCT03217149

heliox for ARDS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 30 minutes to 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

heliox combined with mechanical ventilation (MV)

Experimental group

Description:

heliox combined with mechanical ventilation (MV) is given to infant with ARDS

Treatment:

Drug: heliox combined with MV

mechanical ventilation

Active Comparator group

Description:

mechanical ventilation (MV) is given to infant with ARDS

Treatment:

Drug: MV