Brief Title
NCPAP + Heliox as a Treatment for Infant Respiratory Distress Syndrome (RDS)
Brief 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).
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Efficacy in reducing need of MV
Secondary Outcome
surfactant need
Condition
Respiratory Distress Syndrome
Intervention
NCPAP + standard air
Study Arms / Comparison Groups
NCPAP + standard air
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
51
Start Date
February 2008
Completion Date
September 2010
Primary Completion Date
September 2010
Eligibility Criteria
Inclusion Criteria: - inborn infants between 28 and 32 weeks of GA - Silverman score > 5, - radiological finding of RDS - a requirement of inspiratory flow of oxygen (FiO2) > 0,25 (SaO2 ) between 88-95% within the first hour of life. Exclusion Criteria: - major congenital malformations - intraventricular hemorrhage (IVH) more than grade 2 - need of intubation in the delivery room or requirement of FiO2 >0,4 during the first hour of life.
Gender
All
Ages
28 Weeks - 32 Weeks
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT01383850
Organization ID
Heliox
Study Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study Sponsor
, ,
Verification Date
June 2011