ARDS
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGheliox combined with MV
heliox combined with MV is given to infant with ARDS
DRUGMV
MV is given to infant with ARDS
Sponsors
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Minutes to 28 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| death | within 100 days | death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bayley Scales of Infant Development | at 2 months old and 2 years old | the survival is assessed by Bayley Scales of Infant Development |
Countries
China
Contacts
Primary ContactMa Juan, MD
Backup ContactMa Juan, MD
Outcome results
None listed