NCT01383850

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
• Sex: All
• Age: 28 Weeks – 32 Weeks
• Healthy volunteers: Not accepted

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).

Conditions

• Respiratory Distress Syndrome
• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
OTHER	NCPAP + standard air	NCAP (SiPAP, Vyasis) was used to administer standard air
OTHER	NCPAP + Heliox	Heliox21 (mixture of Helium 80%- Oxygen 20%) (BOC Medical UK- The Linde group) was stored in 10 liter cylinders and administrated through NCPAP for 12 hours (study period) starting from randomization.

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2011-06-28
• Last updated: 2011-06-28

Locations

1 site across 1 country: Italy