Heliox for Neonate With Acute Respiratory Distress Syndrome (ARDS)
- Registration Number
- NCT03217149
- Lead Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- infant less than 28 days
- diagnosis of ARDS
- informed parental consent has been obtained
Exclusion Criteria
- major congenital malformations or complex congenital heart disease
- transferred out of the neonatal intensive care unit without treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description heliox combined with mechanical ventilation (MV) heliox combined with MV heliox combined with mechanical ventilation (MV) is given to infant with ARDS mechanical ventilation MV mechanical ventilation (MV) is given to infant with ARDS
- Primary Outcome Measures
Name Time Method death within 100 days death
- Secondary Outcome Measures
Name Time Method Bayley Scales of Infant Development at 2 months old and 2 years old the survival is assessed by Bayley Scales of Infant Development
Trial Locations
- Locations (1)
Department of Pediatrics, Daping Hospital, Third Military Medical University
🇨🇳Chongqing, Chongqing, China