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NCPAP + Heliox as a Treatment for Infant Respiratory Distress Syndrome (RDS)

Bronchopulmonary Dysplasia Clinical Trial

Clinical Trial Summary

Infants born between 28 and 32 weeks' gestation with radiological findings and clinical symptoms of moderate RDS, requiring respiratory support with Nasal Continuous Positive Airway Pressure (NCPAP) within the first hour of life, were randomized to receive either standard medical air or a Heliox/Oxygen mixture 80/20 (Heliox) during the first 12 hours of life, followed by medical air until NCPAP was needed. The aim of the study was to assess the therapeutic effects of breathing a low-density gas mixture (heliox: 80% helium and 20% oxygen) in premature babies with Respiratory Distress Syndrome (RDS), undergoing NCPAP in terms of reducing the rate of mechanical ventilation (MV).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01383850
Study type Interventional
Source Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Contact
Status Completed
Phase Phase 2
Start date February 2008
Completion date September 2010
View Details
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